Fluid transfer devices and methods of use

ABSTRACT

Fluid transfer systems are disclosed that can be configured to transfer precise amounts of fluid from a source container to a target container. The fluid transfer system can have multiple fluid transfer stations for transferring fluids into multiple target containers or for combining different types of fluids into a single target container to form a mixture. The fluid transfer system can include a pump and a destination sensor, such as a weight sensor. The fluid transfer system can be configured to flush remaining fluid out of a connector to reduce waste, using air or a flushing fluid.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Patent Application No.PCT/US2012/071493, titled “FLUID TRANSFER DEVICES AND METHODS OF USE,”filed Dec. 21, 2012, which claims the benefit of U.S. Provisional PatentApplication No. 61/579,622, titled “FLUID TRANSFER DEVICES AND METHODSOF USE,” filed Dec. 22, 2011. The entire contents of each of theabove-referenced patent applications are incorporated by referenceherein and made a part of this specification. Any and all applicationsfor which a foreign or domestic priority claim is identified in theApplication Data Sheet as filed with the present application areincorporated by reference under 37 CFR 1.57 and made a part of thisspecification.

INCORPORATION BY REFERENCE

U.S. Patent Publication No. 2011/0062703 (the “'703 Publication”),titled “FLUID TRANSFER DEVICES AND METHODS OF USE,” filed on Jul. 28,2010 as U.S. patent application Ser. No. 12/845,548, and published onMar. 17, 2011 is hereby incorporated by reference in its entirety andmade a part of this specification for all that it discloses.

U.S. Pat. No. 5,685,866 (the “'866 patent”), titled “MEDICAL VALVE ANDMETHOD OF USE,” filed on Nov. 4, 1994 as U.S. patent application Ser.No. 08/334,846, and granted on Nov. 11, 1997, is hereby incorporated byreference in its entirety and made a part of this specification for allthat it discloses.

U.S. Patent Publication No. 2008/0287920 (the “'920 Publication”),titled “MEDICAL CONNECTOR WITH CLOSEABLE MALE LUER,” filed on May 8,2008 as U.S. patent application Ser. No. 12/117,568, and published onNov. 20, 2008, is incorporated by reference in its entirety and made apart of this specification for all that it discloses.

U.S. Patent Publication No. 2010/0049157 (the “'157 Publication”),titled “ANTI-REFLUX VIAL ADAPTORS,” filed on Aug. 19, 2009 as U.S.patent application Ser. No. 12/543,776, and published on Feb. 25, 2010,is hereby incorporated by reference in its entirety and made a part ofthis specification for all that it discloses.

U.S. Provisional Patent Application No. 61/557,793 (the “'793application”), filed Nov. 9, 2011, and titled “MEDICAL CONNECTORS WITHFLUID-RESISTANT MATING INTERFACES,” is hereby incorporated by referencein its entirety and made a part of this specification for all that itdiscloses.

PCT Patent Application No. PCT/US2012/054289, filed Sep. 7, 2012, andtitled “MEDICAL CONNECTORS WITH FLUID-RESISTANT MATING INTERFACES,” ishereby incorporated by reference in its entirety and made a part of thisspecification for all that it discloses.

U.S. Patent Publication No. 2011/0282302 (the “'302 Publication”),titled “MEDICAL CONNECTORS AND METHODS OF USE,” filed on May 12, 2011 asU.S. patent application Ser. No. 13/106,781, and published on Nov. 17,2011, is hereby incorporated by reference in its entirety and made apart of this specification for all that it discloses.

BACKGROUND

Field of the Disclosure

Some embodiments of the invention relate generally to devices andmethods for transferring fluid and specifically to devices and methodsfor transferring medical fluids.

Description of the Related Art

In some circumstances it can be desirable to transfer one or more fluidsbetween containers. In the medical field, it is often desirable todispense fluids in precise amounts and to store and to transportpotentially dangerous fluids. Current fluid transfer devices and methodsin the medical field suffer from various drawbacks, including high cost,low efficiency, intensive labor demands, and excessive fluid or vaporleakage. Some embodiments disclosed herein overcome one or more of thesedisadvantages.

SUMMARY OF SOME EMBODIMENTS

Some embodiments disclosed herein relate to systems and methods fortransferring fluid from source containers to target containers.

In one embodiment a medical fluid transfer system includes a hoseassembly having a first closable connector configured to couple to asource container and a second closable connector configured to couple toa target container. The system also includes a pump configured totransfer fluid through the hose assembly. The system also includes adestination sensor configured to output information about the secondcontainer. The system also includes a control system configured toreceive instructions, including a fluid transfer instruction, operatethe pump based on the fluid transfer instructions, receive informationabout the second container from the destination sensor, and operate thepump based on the information received from the destination sensor.

In some embodiments of the medical fluid transfer system, thedestination sensor can be a weight sensor. The pump can be a positivedisplacement pump or a peristaltic pump. The control system can beconfigured to operate the peristaltic pump at variable speeds.

In some embodiments the hose assembly can have an elastomeric portion.The hose assembly can have a first connector and a second connector. Thefirst connector can be configured to removably couple to the firstcontainer and the second connector can be configured to removably coupleto the second container. The first connector can be a closable maleconnector and the second connector can be a closable male connector. Themedical fluid transfer system can further include a sensor configured todetect whether the second connector is open.

In some embodiments the medical fluid transfer system can include areservoir container. The reservoir container includes a reservoir bodyhaving an outer wall forming an internal cavity, the outer wall can beflexible. The reservoir container also includes a first engagementinterface configured to couple to the first container. The reservoircontainer also include a second engagement interface coupled to the hoseassembly. The reservoir container can be operable to transfer fluid fromthe first container to the internal cavity by compressing anddecompressing the outer wall.

In some embodiments the control system can be configured to receiveinstructions from a remote source. The medical fluid transfer system canfurther include a scanner configured to scan information on the firstcontainer and the second container. The control system can be configuredto receive information from the scanner and store the informationreceived from the scanner.

In an embodiment of a method of transferring fluid using a medical fluidtransfer system, the method includes receiving instructions, theinstructions identifying a specified volume of fluid to transfer from asource container to a target container. The method also includestransferring fluid from the source container to the target container,wherein fluid is transferred via a hose assembly by a pump, wherein thehose assembly has a first closable connector coupled to the targetcontainer and a second closable connector coupled to the targetcontainer. The method also includes receiving information from adestination sensor, wherein the information identifies the amount offluid transferred to the source container. The method also includesstopping the transfer of fluid when the specified volume of fluid istransferred to the target container based on the information receivedfrom the destination sensor.

In some embodiments the pump can be a peristaltic pump. The destinationsensor can be a weight sensor and the information is the weight of thefluid transferred to the source container.

In some embodiments the method also includes preparing the weight sensorfor the transfer of fluid by accounting for the weight of the targetcontainer prior to transferring fluid from the source container to thetarget container. In some embodiments the method also includes receivingan indication from the destination sensor that fluid is not beingtransferred to the target container, determining based on theinformation received from the destination sensor that the fluid from thesource container has been depleted, and notifying a user that the sourcecontainer has been depleted.

In some embodiments, the method can also include determining a thresholdamount of fluid transferred from the source container to the targetcontainer, the threshold is an amount of fluid less than specifiedvolume of fluid to transfer to the target container, identifying whenthe threshold has been satisfied based on information received from thedestination sensor, and adjusting operational parameters of the pump toslow down the rate at which fluid is transferred from the sourcecontainer after the threshold has been satisfied. The method can alsoinclude prompting a user to decouple the source container from the fluidtransfer system when the fluid from the source container is depleted.

An embodiment of a hose assembly for the transfer of medical fluidsincludes a hose having a proximal end and a distal end. An elastomericportion can be disposed between the proximal end and the distal end, theelastomeric portion can have a first portion and a second portion. Thesecond portion can be more flexible than the first portion. The secondportion is configured to couple to a peristaltic pump. The hose assemblyalso includes a first closable male connector coupled to the proximalend of the hose, the first connector configured to couple to a sourcecontainer. The hose assembly also includes a second closable maleconnector coupled to the distal end of the hose, the second connectorconfigured to couple to a target container. The hose assembly isconfigured to form a fluid flow path from the source container to thetarget container.

In an embodiment of a medical fluid transfer system for flushing aconnector having a residual fluid contained therein, the system includesa fluid transfer station having a connector and a control system. Theconnector has a source connection portion and a target connectionportion. The connector has a residual volume of a transfer fluidcontained therein. The control system can be configured to draw aflushing fluid into the connector through the source connection portion,and drive at least a portion of the flushing fluid towards the targetconnection portion to expel at least a portion of the residual fluidfrom the connector.

In some embodiments of the medical fluid transfer system, the portion ofresidual fluid can be substantially all the residual fluid from theconnector. The flushing fluid can be air. The control system can beconfigured to provide a prompt to a user to attach or confirm attachmentof a flush receiving container to the target connection portion of theconnector. The target connection portion of the connector can beconfigured to couple to a flush receiving container, the flush receivingcontainer can be a source container for use during a fluid transferoperation. The flush receiving container can use the same type of fluidas the residual fluid. The control system can be further configured toreceive instructions. The instructions can include fluid transferinstructions for transferring a specified volume of the transfer fluid.The control system can be further configured to actuate a fluid switchto close a fluid connection between the source connection portion of theconnector and the transfer fluid and to establish a fluid connectionbetween the source connection portion of the connector and the flushingfluid.

In some embodiments the medical fluid transfer system can also include apump and the connector can be a hose assembly. The control system can befurther configured control operation of the pump to draw a flushingfluid into the connector through the source connection portion and todrive at least a portion of the flushing fluid towards the targetconnection portion to expel at least a portion of the residual fluidfrom the connector.

In some embodiments the medical fluid transfer system can also include asyringe having a plunger and coupled to the connector. The controlsystem can be further configured to retract the plunger on the syringewherein retracting the plunger is configured to draw a flushing fluidinto the connector through the source connection portion and advance theplunger to drive at least a portion of the flushing fluid towards thetarget connection portion to expel at least a portion of the residualfluid from the connector. The control system can be further configuredto retract the plunger a second time to draw additional flushing fluidinto the connector through the source connection portion, and advancethe plunger a second time to drive at least a portion of the flushingfluid towards the target connection portion to expel at least a portionof the remaining residual fluid from the connector. The control systemcan be further configured to receive instructions, including fluidtransfer instructions for transferring a specified volume of thetransfer fluid. The control system can be further configured tocalculate a transfer fluid sub-volume, the transfer fluid sub-volumebeing smaller than the specified volume of the transfer fluid, transferthe transfer fluid sub-volume from a source container to a targetcontainer by actuating the syringe plunger, and stop the fluid transferto leave the residual volume of the transfer fluid in the connector asthe residual fluid. Advancing the plunger can drive an expelled volumeof the residual fluid into the target container, and the transfer fluidsub-volume and the expelled volume combine to substantially equal thespecified volume of the transfer fluid. The fluid transfer instructionscan further include a specified volume of a diluting fluid. The systemcan be further configured to calculate a diluting fluid sub-volume, thediluting fluid sub-volume being smaller than the specified volume of thediluting fluid and transfer the diluting fluid sub-volume into thetarget container. The diluting fluid can be configured to be used as theflushing fluid. When advanced, the plunger can expel a diluting fluidflush volume of the diluting fluid into the target container, and thediluting fluid sub-volume and the diluting fluid flush volume combine tosubstantially equal the specified volume of the diluting fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of the invention will now be discussed in detailwith reference to the following figures. These figures are provided forillustrative purposes only, and the embodiments are not limited to thesubject matter illustrated in the figures.

FIG. 1 schematically shows an example embodiment of an automated systemfor transferring fluid.

FIG. 2 is a perspective view of an example embodiment of an automatedsystem for transferring fluid.

FIG. 3 is a front view of the system of FIG. 2.

FIG. 4 is a back view of the system of FIG. 2.

FIG. 5 is a perspective view of an example embodiment of a fluidicsassembly that can be used to transfer fluid.

FIG. 6 is an exploded view of the fluidics assembly of FIG. 5.

FIG. 7 shows an example embodiment of a vial and a vial adapter that canbe used in the fluidics assembly of FIG. 5.

FIG. 8 is a cross sectional view of the vial and vial adapter of FIG. 7.

FIG. 9 is a perspective view of an example embodiment of a connectorthat can be used with the fluidics system of FIG. 5.

FIG. 10 is another perspective view of the connector of FIG. 9.

FIG. 11 is an exploded view of the connector of FIG. 9.

FIG. 12 is another exploded view of the connector of FIG. 9.

FIG. 13 is a cross sectional view of the connector of FIG. 9, showing afirst fluid flow path through the connector.

FIG. 14 is another cross sectional view of the connector of FIG. 9,showing a second fluid flow path through the connector.

FIG. 15 shows an example embodiment of an IV bag assembly that can beused with the fluidics system of FIG. 5.

FIG. 16 shows another example embodiment of an IV bag assembly that canbe used with the fluidics system of FIG. 5.

FIG. 17 is a perspective view of an example embodiment of a maleconnector portion that can be used for the connector of FIG. 9.

FIG. 18 is a front view of the male connector portion of FIG. 17.

FIG. 19 is an exploded view of the male connector portion of FIG. 17.

FIG. 20 is a cross sectional view of the male connector portion of FIG.17 with a female connector in an unengaged configuration.

FIG. 21 is a cross sectional view of the male connector portion of FIG.17 with a female connector in an engaged configuration.

FIG. 22 shows an example embodiment of a transfer station having aconnector and syringe attached thereto by a mounting module.

FIG. 23 shows an example embodiment of a cassette that an be used withthe mounting module of FIG. 22.

FIG. 24 is a partially transparent view of the cassette of FIG. 23.

FIG. 25 is a cross sectional view of the connector of FIG. 22.

FIG. 26 is a cross sectional view of the connector of FIG. 22 takenthrough a sensor beam intersection plane.

FIG. 27 is a cross sectional view of the male connector portion of theconnector of FIG. 22 taken through a sensor beam intersection plane.

FIG. 28 shows an example embodiment of a transfer station having a trayattached thereto for supporting an IV bag.

FIG. 29 is a perspective view of an example attachment for supporting anIV bag in a hanging configuration.

FIG. 30 is a perspective view of a transfer station using the attachmentof FIG. 29 to hang an IV bag in a substantially vertical configuration.

FIG. 31 shows the attachment of FIG. 29 with an support member and IVbag attached thereto.

FIG. 32 shows the fluid transfer system of FIG. 2 using a fluid bag as afluid source container and having a foot pedal.

FIG. 33 shows the fluid transfer system of FIG. 2 positioned inside anexample embodiment of a fume hood.

FIG. 34 is a flow diagram illustrating an example embodiment of a methodfor operating a fluid transfer device in a fume hood.

FIG. 35 shows a connector for a transfer station of the system of FIG.2.

FIG. 36 shows an example embodiment of a fluid transfer system having atransfer station configured to transfer fluids that may not bedangerous, expensive, and/or sensitive, such as for reconstitutionand/or dilution of medication.

FIG. 37 shows an example embodiment of a vial adapter that can be usedwith the fluid transfer system of FIG. 36.

FIG. 38 shows the vial adapter of FIG. 37 with a vial attached thereto.

FIG. 39 shows the vial adapter and vial of FIG. 38, having a vialadapter bag in a deflated configuration.

FIG. 40 shows the vial adapter and vial of FIG. 38, having a vialadapter bag in an inflated configuration.

FIG. 41 shows an example embodiment of a connector and upper mountingmodule that can be used with a fluid transfer system.

FIG. 42 shows a male connector portion of the connector of FIG. 41 alongwith a corresponding female connector in an unengaged configuration.

FIG. 43 shows the fluid transfer system of FIG. 2 with an exampleembodiment of an elastomeric pump attached thereto.

FIG. 44 is an example embodiment of a method for filling an elastomericpump.

FIG. 45 is an example embodiment of a method for flushing a connector.

FIG. 46 is a cross sectional view of an air source attachment.

FIG. 47 is an example embodiment of a method for flushing a connector.

FIG. 48 is a cross sectional view of a connector showing variousportions of a fluid pathway through the connector.

FIG. 49 is a cross sectional view of another example embodiment of aconnector.

FIG. 50 is an example embodiment of a method for transferring fluid thatincludes flushing a connector.

FIG. 51 is another example embodiment of a method for transferring fluidthat includes flushing a connector.

FIG. 52 is a schematic view of an example embodiment of a sourceswitching system.

FIG. 53 shows an example embodiment of a reservoir container.

FIG. 54 shows a cross section of the reservoir container from FIG. 53.

FIG. 55 is a perspective view of an example embodiment of a fluidicsassembly that can be used to transfer fluid.

FIG. 56 is an exploded view of the fluidics assembly of FIG. 55.

FIGS. 57 and 58 illustrate usage of a reservoir container in a fluidicsassembly.

FIG. 59 is an example embodiment of a method for using a reservoircontainer in a fluidics assembly.

FIG. 60 schematically shows an example embodiment of an automated systemfor transferring fluid.

FIG. 61 is a view of an example embodiment of an automated system fortransferring fluid.

FIG. 62 is a front view of the system of FIG. 61.

FIG. 63 is a back view of the system of FIG. 61.

FIG. 64 is a perspective view of an example embodiment of a fluidicsassembly that can be used to transfer fluid.

FIG. 65 is an exploded view of the fluidics assembly of FIG. 64.

FIGS. 66 through 68 illustrate usage of an embodiment of a peristalticpump.

FIG. 69 is an example embodiment of a method for using an automatedsystem for transferring fluid.

FIG. 70 is an example embodiment of a method of flushing a fluid.

FIG. 71 is an example embodiment of a method for using a workflow and/ordata management system.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS

The following detailed description is now directed to certain specificexample embodiments of the disclosure. In this description, reference ismade to the drawings wherein like parts are designated with likenumerals throughout the description and the drawings.

In many circumstances fluid is transferred from a source container to atarget container. In some instances, it can be desirable to transferprecise amounts of a fluid, such as a medication, into the targetcontainer. For example, in some embodiments a medication can be storedin a vial or other container, and a precise dosage amount of themedication can be extracted and transferred to a target device so thatthe dosage amount can be delivered to a patient. In some embodiments,fluid from multiple source containers can be combined, or compounded,into a single target container. For example, in some embodiments amixture of medications can be created in the target container, or aconcentrated medication can be combined with a diluent in the targetcontainer. To achieve the desired proportions of fluids, it can bedesirable to precisely measure the amounts of fluids transferred intothe target container. Also, precisely measuring the amount of fluidtransferred from the source container to the target container can reducethe amount of fluid wasted (e.g., when more fluid than necessary iswithdrawn from the source container). Reduction of waste is desirablebecause, for example, in some instances the fluid being transferred canbe expensive.

Some embodiments disclosed herein provide fluid transfer devices fortransferring precise amounts of fluid from one or more source containersinto one or more target containers.

In some embodiments, it can be desirable to transfer fluids from asource container to a target container using a sealed system. In someembodiments, exposing the fluid to ambient air can allow contaminants toenter the fluid or cause an undesirable reaction with the fluid. Somemedications (e.g., chemotherapy medications) can be harmful to anunintended recipient. Therefore, it can be desirable to prevent orreduce exposure of the fluid being transferred to the ambient air orarea outside the fluid transfer system. In some embodiments, a fluidtransfer system that prevents or reduces exposure of the fluid to thearea outside the fluid transfer system can render other expensiveequipment (e.g., a clean room) unnecessary, thereby reducing the costassociated with transferring the fluids.

Some embodiments disclosed herein provide a fluid transfer device fortransferring fluid while preventing, reducing, or minimizing the amountof contact the fluid has with the ambient air or area outside the fluidtransfer system.

FIG. 1 schematically shows an embodiment of an automated fluid transfersystem 100. The system 100 can include a housing 102 enclosing acontroller 104 and a memory module 106. The system 100 can also includea user interface 108, which can be, for example, external to the housing102. The user interface 108 can also be integrated into the housing 102in some cases. The user interface 108 can include, for example, adisplay, a keypad, and/or a touch screen display. The user interface 108can be configured to receive instructions from the user, for example,regarding the amounts of fluid to be transferred and the types of fluidsto be transferred. The user interface can also be configured to provideinformation to the user, such as error messages, alerts, or instructions(e.g., to replace an empty vial). Although in the embodiment shown, thecontroller 104 and memory module 106 are contained within the housing102, a variety of other configurations are possible. For example,controller 104 can be external to the housing 102, and can be, forexample contained within a second housing, which may also contain theuser interface 108. In some embodiments, the system 100 can include acommunication interface 110 configured to receive information (e.g.,instructions) from a remote source such as an external controller 112, aterminal (such as a computer) 114, or an automated management system(such as a hospital information system (HIS)) 116, etc. In someembodiments, the communication interface can also send information(e.g., results or alerts) to the remote source. The communicationinterface can include one or more connection types and can be configuredto allow connectivity to multiple remote sources at once. In someembodiments, the system 100 does not include a communication interface105 and does not communicate with a remote source.

The system 100 can include multiple transfer stations 118 a-b. In theembodiment shown, the system 100 includes two transfer stations 118 a-b,but a different number of transfer stations can be used. For example, insome embodiments, the system may include a single transfer station. Inother embodiments, the system may include two, three, four, five, six,seven, eight, or more transfer stations depending on the number ofdifferent fluid types the system is designed to handle and the amount offluid to be transferred.

Each transfer station 118 a-b can include a fluid source container 120a-b, which can be, for example, a medical vial or other suitablecontainer such as a bag, a bottle, or a vat, etc. Although manyembodiments disclosed herein discuss using a vial as the sourcecontainer, it will be understood the other containers can be used evenwhen not specifically mentioned. In some embodiments, each of the sourcecontainers 120 a-b can contain a unique fluid, providing a variety offluids that the user can select for transfer. In other embodiments, twoor more of the source containers 120 a-b can contain the same fluid. Insome embodiments, the source containers 120 a-b include bar codes thatidentify the types of fluid contained therein. The bar codes can bescanned by a bar code scanner 105 that is in communication with thecontroller 104 and/or the memory 106 (e.g., via the communicationinterface 110) so that the identities of the fluids contained by sourcecontainers 120 a-b can be stored within the memory module 106. In someembodiments, the fluid transfer stations 118 a-b are configured totransfer precise amounts of fluid from source containers 120 a-b totarget containers 124 a-b, which can be, for example IV bags. It will beunderstood that in various embodiments described herein, a differenttype of target connector or destination container can be used instead ofan IV bag (e.g., a syringe, a bottle, a vial, an elastomeric pump, etc.)even when not specifically mentioned. In some embodiments the fluid canfirst be transferred from source containers 120 a-b to intermediatemeasuring containers 122 a-b so that a precise amount of fluid can bemeasured. The intermediate measuring containers 122 a-b can be, forexample, syringes. After being measured, the fluid can be transferredfrom intermediate measuring containers 122 a-b to the target containers124 a-b.

The fluid transfer system 100 can be used to transfer individual fluidsfrom the source containers 120 a-b to separate target containers 124a-b, or to transfer and combine fluids from multiple source containers120 a-b into a common target container (e.g., 124 a in FIG. 1). In theembodiment shown in FIG. 1, when combining fluids from both fluid sourcecontainers 120 a-b into a common target container 124 a, the othertarget container 124 b can be omitted, and the fluid can be driven alongthe path shown by the dotted line from the connector 126 b to the targetcontainer 124 a. Thus, system 100 can be used for compounding mixturesof fluids. For example, the system 100 can be used to combine multiplemedications together or to combine feeding fluids (e.g., water,dextrose, lipids, vitamins, minerals). The system 100 can also be usedto dilute a medication or other fluid to a desired concentration level.Thus, in some embodiments, a first fluid transfer station 118 a caninclude a concentrated medication or other fluid, and a second fluidtransfer station 118 b can include saline or other diluent. The system100 can be configured to receive input (e.g., from a user or from a HIS)indicating a desired amount and concentration of medication, and thesystem 100 can be configured to transfer the precise amounts of theconcentrated medication and the diluent required to fill the sourcecontainer 124 a with the desired amount and concentration of themedication.

In some embodiments, a single system can be configured both forcompounding mixtures of fluids and for the transfer of individual fluidsfrom a single-source container to a single-target container. Forexample, a system containing six fluid transfer stations can beconfigured so that transfer stations 1-3 are dedicated to compoundingmixtures of fluids into a single common target container, while fluidtransfer stations 4-6 can be configured to each transfer fluid from asingle source container to a single target container. Otherconfigurations are possible.

In some embodiments, one or more of the transfer stations 118 a-b caninclude one or more pairs of male and female fluid connectors configuredto be attached to each other to selectively permit the passage of fluid.The connectors can be detached or disconnected, for example, so that thetarget container 124 a-b can be removed once the fluid has beentransferred. In some embodiments, the connectors can be configured toautomatically close when disconnected from a corresponding connector,thereby preventing fluid from escaping when the connectors are detached.Thus, the fluid transfer system 100 can be used to transfer fluid whileretaining substantially entirely, or entirely, all of the fluid withinthe system, permitting the fluid transfer to occur in a substantiallyentirely, or entirely, closed system. The fluid transfer system 100 canthereby reduce or eliminate the risk of injury, waste, or damage causedby liquid or vapor leakage when connecting and disconnecting thecomponents of the fluid transfer system 100.

In some embodiments, the system 100 can be configured to be compatiblewith a variety of sizes of syringes (e.g., 10 ml, 20 ml, 50 ml, and 100ml). For example, larger volume syringes can be used to transfer largervolumes of fluid in shorter amounts of time. Smaller volume syringes canbe used to increase the accuracy and precision with which amounts offluid can be transferred. In some embodiments, the syringes can includea bar code which identifies the volume of the syringe. The bar code canbe scanned by a bar code scanner 105, so that the sizes of the syringesused by the different transfer stations 118 a-b can be stored withinmemory module 106 for use by the controller 104.

In some embodiments, connectors 126 a-b connects the source containers120 a-b, the intermediate containers 122 a-b, and the target containers124 a-b. In some embodiments, the connectors 126 a-b can include firstcheck valves (not shown) configured to allow fluid to flow from thesource container 120 a-b into the connector 126 a-b, and block fluidfrom flowing from the connector 126 a-b into the source container 120a-b, as shown by single-headed arrows. The connectors 126 a-b can alsoinclude second check valves (not shown) configured to allow fluid toflow from the connector 126 a-b into the target container 124 a-b, butblock fluid from flowing from target container 124 a-b into connector126 a-b, as shown by single-headed arrows. In some embodiments, theconnectors 126 a-c can be in two-way fluid communication with theintermediate containers 122 a-b, as shown by double-headed arrows.

In some embodiments, the system 100 can include mounting modules 128 a-bfor mounting the transfer stations 118 a-b onto the housing 102. Forexample, in some embodiments the mounting modules 128 a-b can beconfigured to receive intermediate measuring containers 122 a-b, asshown in FIG. 1, to secure the transfer stations 118 a-b onto thehousing. The mounting modules 128 a-b can also engage the connectors 126a-b or other portions of the fluid transfer stations 118 a-b. Forexample, in some embodiments, the connectors 126 a-b can include a ridgeor channel that is configured to interface with a corresponding channelor ridge in the mounting modules 128 a-b, to facilitate precisepositioning of the fluid transfer stations with respect to the housing102 and other components. The system 100 can also include motors 130a-b, which can be for example, contained within the housing 102. Themotors 130 a-b can be configured to actuate the intermediate measuringcontainers 122 a-b to draw fluid into the containers (from the sourcecontainers 120 a-b) and to dispel fluid therefrom (into the targetcontainers 124 a-b). The motors 130 a-b can be in communication with thecontroller 104 and can receive actuation instructions from thecontroller 104. For example, the intermediate containers 122 a-b canoperate as precision syringe pumps to transfer precise amounts of fluidwith the motors configured in some embodiments to actuate plungers onthe syringes to draw fluid into the syringes. The motors 130 a-b andautomated system 100 allow for precise transfer of fluids at a fasterand more consistent rate than using a syringe pump by hand. For example,a large syringe (e.g., 50 ml or 100 ml) can require significant effortto manipulate the plunger, which can be difficult to perform by hand,especially if done repeatedly. The motors 130 a-b and automated system100 can increate the precision, consistency, and rate of fluid transfer.

In some embodiments, the system can include fluid detectors 132 a-bconfigured to detect a presence or absence of fluid in connectors 120a-c or at other locations in the fluid transfer stations 118 a-b. Thefluid detectors 132 a-b can be in communication with the controller 104so that when the detectors 132 a-b detect an absence of fluid, which canindicate that source fluid containers 120 a-b have run dry, thedetectors 132 a-b can send a signal to the controller 104 indicatingthat a source container 120 a-b may need to be replaced. The fluiddetectors 132 a-b can be, for example, infrared LEDs and photodetectors, or other types of electronic eyes, as will be discussed inmore detail below. In the embodiment shown, fluid detectors 132 a-b areshown connected to connectors 126 a-b, but other configurations arepossible. For example, fluid detectors 132 a-b can be connected to fluidsource containers 120 a-b themselves. In some embodiments, multiplefluid detectors can be used in the same general location of a singletransfer station 118 a-b. For example, a first sensor can be configuredto detect a first type of fluid (e.g., alcohol-based fluids), and asecond sensor can be configured to detect a second type of fluid (e.g.,non-alcohol-based fluids).

In some embodiments, the system 100 can include compatibility modules127 a-b for preventing connectors other than approved connector 126 a-bfrom being placed in communication with the system 100. By allowing onlyapproved connectors 126 a-b to be used with the system 100, thecompatibility modules 127 a-b can prevent inaccuracies in fluidtransfers which may occur if an unapproved connector is used (e.g.,which may have an internal volume different than approved connectors 126a-b). The compatibility modules 127 a-b can be, for example, aspecifically shaped mounting feature (e.g., on the mounting modules 128a-b) that is configured to interface with a corresponding portion of theconnector 126 a-b. The compatibility modules 127 a-b can be one or moresensors configured to detect the presence of an approved connector 126a-b or to align with a specific portion of the connector 126 a-b duringoperation.

In some embodiments, the system 100 can include source adapters 136 a-bconfigured to receive the source containers 120 a-b and removablyconnect to the connectors 126 a-b. Thus, when a source container 120 a-cruns out of fluid, the empty source container 120 a-b and itscorresponding adapter 136 a-b can be removed and replaced withoutdisengaging the associated connector 126 a-b from the housing 102. Insome embodiments, source adapters 136 a-b can be omitted, and the sourcecontainers 120 a-b can be directly received by the connectors 126 a-b.

In some embodiments the system 100 can include sensors 134 a-b fordetecting the presence of target containers 124 a-b. Sensors 134 a-b canbe in communication with the controller 104 so as to prevent the system100 from attempting to transfer fluid when no target container 124 a-bis connected. A variety of sensor types can be used for sensors 134 a-b.For example, sensors 134 a-b can be weight sensors, sensor pads,infrared sensors, or other forms of electronic eyes. In someembodiments, weight sensors 134 a-b can also be used to measure theweight of the target containers 124 a-b after fluid has beentransferred. The final weight of a target container 124 a-b can becompared to an expected weight by the controller 104 to confirm that theproper amount of fluid was transferred into the target container 124a-b. In some embodiments, the sensor 134 a-b can align with asubstantially transparent portion of the connector 126 a-b to detectwhether a valve on the connector 126 a-b leading to target container 124a-b is open. If open, the sensor 134 a-b can send a signal to thecontroller 104 so that fluid transfer is permitted. The sensors 134 a-bcan be configured to align properly with only approved connectors 126a-b so that the sensors 134 a-b do not allow fluid transfer if anunapproved connector is used. Thus, the sensors 134 a-b can be used asthe compatibility modules 127 a-b in some embodiments.

The fluid transfer system 100 can be modified in many ways. For example,as mentioned above, the system 100 can have a different number oftransfer stations than the two shown in the illustrated embodiment.Also, in some embodiments, certain features shown in FIG. 1 can beomitted for some or all of the transfer stations. For example, in someembodiments, a fluid transfer station that is dedicated to the transferof fluids that are not dangerous, expensive, or sensitive to ambient air(e.g., saline or water) can have fewer leak-preventing features than thefluid transfer stations dedicated to the transfer of fluids that aredangerous, expensive, or sensitive to ambient air. Thus, if fluidtransfer station 118 b were dedicated to the transfer of saline (e.g.,to be used as a diluent), the sensor 134 b could be omitted, in somecases. Without the sensor 134 b, the system 100 could permit fluid to beexpelled from the connector 126 b when no target container 124 a-b isattached, which could cause the fluid to leak. However, because salineis not a dangerous, expensive, or sensitive fluid, the possibility ofleaking saline can be tolerated.

FIG. 2 is a perspective view of an example embodiment of a fluidtransfer system 200, which can have features similar to, or the same as,the system 100 described above or any other fluid transfer systemdescribed herein. FIG. 3 is a front view of the fluid transfer system200 and FIG. 4 is a back view of the fluid transfer system 200. In FIGS.3 and 4, certain features (e.g., the target and source containers andtubing) are omitted from view. The system 200 can include a housing 202,and a user interface 208 can be incorporated into the housing. The userinterface 208 can include a touchscreen, a keypad, a display, or othersuitable interface devices for providing information to a user and/orfor providing input from the user to a controller (not shown).

As can be seen in FIG. 4, the system 100 can have a communicationinterface 210 which can include one or more connection points to receivecables from one or more remote sources such as a remote terminal (e.g.,a computer) or an automated management system (e.g., a hospitalinformation system (HIS)). The communication interface 210 can beconfigured to provide a communication link between the system 200 and aremote source. The communication link can be provided by a wirelesssignal (e.g., using an antenna) or by one or more cables or acombination thereof. The communication link can make use of a networksuch as a WAN, a LAN, or the internet. In some embodiments, thecommunication interface 210 can be configured to receive input (e.g.,fluid transfer commands) from the remote source and/or can provideinformation (e.g., results or alerts) from the system to the remotesource.

In the illustrated embodiment, the system 200 has two fluid transferstations 218 a-b. In some embodiments, the first transfer station 218 acan be configured to provide a closed fluidics system suitabletransferring dangerous, expensive, or sensitive fluids without, orsubstantially without, leakage or exposure to ambient air. In someembodiments, the second transfer station 218 b can be configureddifferently than the first transfer station 218 a. For example, thesecond transfer station 218 b can be configured to transfer a fluid thatis not dangerous, expensive, or sensitive (e.g., saline or water), whichin some cases can be used as a diluent for diluting fluids transferredby the first transfer station 218 a. Thus, in some cases the secondfluid transfer station 218 b can include fewer leak-prevention featuresthan the first fluid transfer station 218 a, as will be describedherein, which can provide less complexity and reduced cost.

The first fluid transfer station 218 a can be configured to transferfluid from a vial 220 a, through a connector 226 a, and into a syringe222 a when the syringe plunger is retracted. When the syringe plunger isadvanced, the fluid can be driven out of the syringe 222 a, through theconnector 226 a, and into an IV bag 224 a. The first fluid transferstation 218 a can include a mounting module 228 a configured to receivethe syringe 222 a, the connector 226 a, the vial 220 a, the IV bag 224a, or some combination thereof for mounting to the housing 202. Themounting module 228 a can engage the syringe 222 a so that a motor(e.g., a step motor) can precisely retract and advance the syringeplunger to transfer the fluid from the vial 220 a to the IV bag 224 a.

In the configuration shown in FIG. 2, the second fluid transfer station218 b is configured to transfer fluid from a second fluid sourcecontainer 220 b (e.g., a vial or fluid bag) to a second fluid targetcontainer 224 b (e.g., a vial). In some embodiments, the second fluidtransfer station can be used to transfer a reconstituting fluid or adiluent (e.g., saline or water). For example, in the configuration shownin FIG. 2, the fluid from vial 220 b can be used to reconstitute amedication (e.g., in powdered form) contained in the vial 224 b, or canbe used to dilute a concentrated medication in the vial 224 b. In someembodiments, the second fluid transfer station 218 b can be used totransfer fluid to the same IV bag 224 a used by the first fluid transferstation 218 a, for example, to dilute the medication transferred intothe IV bag 224 a from the vial 220 a. The second fluid transfer station218 b can include a syringe 222 b which can be mounted onto the housing202 by a mounting module 228 b so that a motor can precisely retract andadvance the plunger of the syringe 222 b to transfer fluid. When thesyringe plunger is retracted, fluid can be drawn from the vial 220 b,through a connector 226 b, and into the syringe 222 b. When the syringeplunger is advanced, the fluid can be driven from the syringe 222 b,through the connector 226 b, and into the vial 224 b (or into the IV bag224 a).

A tube 230 can extend from an inlet on the connector 226 b toward thefluid source container 220 b. A connector 232 (e.g., a Spiros® closeablemale connector manufactured by ICU Medical, Inc., of San Clemente,Calif.) can be located at the end of the tube 230 and can be used toconnect to a corresponding connector 234 (e.g., a Clave® connectormanufactured by ICU Medical, Inc., of San Clemente, Calif.) that isattached to the fluid source container 220 b. Additional detailsrelating to Clave® connectors and some variations are disclosed in the'866 patent. In various embodiments disclosed herein, other types ofconnectors can also be used, such as a MicroCLAVE® connector(manufactured by ICU Medical, Inc., of San Clemente, Calif.), or anyother connector disclosed or described herein, including those in the'302 application, including, for example, clear connectors. When theconnectors 232 and 234 are engaged, a fluid connection exists betweenthe fluid source container 220 b and the connector 226 b. A tube 236 canextend from an outlet of the connector 226 b and a connector (e.g., aSpiros® closable male connector) can be positioned at the end of thetube 236. A corresponding connector 240 (e.g., a Clave® connector) canengage the connector 238 to provide a fluid connection between theconnector 226 b and the vial 224 b. The IV bag 224 a may have asupplemental line of tubing 225 that can be configured to engage theconnector 238 to provide a fluid connection between the connector 226 band the IV bag 224 a.

The system 200 can include a pole assembly 242, which can be configuredto hold fluid containers such as vials and fluid bags. A pole 244 canextend upward from the housing 202, and in some embodiments, the pole244 can be height adjustable and thumb screw 246 can be tightened tohold the pole 244 in place. The thumb screw 246 can be loosened toenable adjustment of the height of the pole 244, and in someembodiments, the pole 244 can be lowered into a recess formed in thehousing 202 that is configured to receive the pole 244. Thus, the pole244 can be entirely, substantially entirely, or mostly withdrawn intothe housing 202 when the pole 244 is not in use (e.g., during storage ortransportation or when not needed to support fluid containers). One ormore support modules 248 can be attached to the pole 244 and can beconfigured to support fluid containers. The support modules 248 caninclude thumb screws so that the positions of the support modules 248 onthe pole 244 can be adjustable, and/or so that the support modules 248can be removable from the pole 244. In the illustrated embodiment, afirst support module 248 a can be used to support the vial 220 a, andcan have a hook 250 (e.g., for hanging a fluid bag). A second supportmodule 248 b can have one or more curved arms 252 for supporting a fluidcontainer such as vial 220 b.

FIG. 5 is a perspective view of a fluidics assembly 3906 that can beused with the first fluid transfer station 218 a. FIG. 6 is aperspective exploded view of the fluidics assembly 3906 from a differentangle than that shown in FIG. 5. The fluid assembly 3906 can be used totransfer precise amounts of fluid from a vial 3907 to an IV bag 3914.The fluidics assembly 3906 includes a vial 3907, a vial adapter 3908configured to provide fluid communication with the fluid (e.g.,chemotherapy drug or other medication) contained within the vial 3907, asyringe 3912, an IV bag assembly 3914, and a connector 3910 fordirecting fluid from the vial adapter 3908 into the syringe 3912 andfrom the syringe 3912 toward the IV bag assembly 3914. In someembodiments, the fluidics assembly 3906 can have features similar to, orthe same as, those of the other fluidics systems disclosed herein. Forexample, the connector 3910 can be the same or substantially similar tothe connector 226 a, also discussed herein. In some embodiments, thefluidics assembly 3906 can be configured to allow the vial 3907 and vialadapter 3908 to be replaced (e.g., when the vial runs out of fluid)without replacing the connector 3910 or syringe 3912. In someembodiments, the vial adapter 3908 can be configured to allow air toenter the vial 3907 via the vial adapter 3908, thereby substantiallyequalizing pressure in the vial 3907 as fluid is drawn out.

FIG. 7 a perspective view showing the vial adapter 3908 and the vial3907 in a separated configuration, such as before the vial 3907 isattached to the vial adapter 3908. The upper portion 3940 of the vialadapter 3908 can include a spike 3942 configured to pierce the septum onthe cap of the vial 3907 and arms 3940, 3943 configured to retain thevial 3907 onto the vial adapter 3908.

Opposite the upper portion 3940, the vial adapter can include aconnector, which can be, for example, a female connector 3944. Theconnector 3944 can be, for example, a version of the Clave® connectormanufactured by ICU Medical, Inc., of San Clemente, Calif. Variousembodiments of a connector of this type are described in the '866patent. The female connector 3944 can seal the end of the vial adapter3908 such that no fluid is allowed to escape from the vial adapter 3908until a male connector is attached to the female connector 3944. Itshould be understood that in many embodiments discussed herein, the maleand female connectors can be switched. For example, the vial adapter3908 can include a male connector which is configured to mate with afemale connector on the connector 3910.

The vial adapter 3908 can include an air intake channel 3946 configuredto direct air into the vial 3907 to compensate for fluid removed fromthe vial 3907 to reduce the pressure differential. The air intakechannel 3946 can include a filter 3948 configured to allow air to passthrough the filter 3948 and toward the vial 3907 while also preventingfluid from passing through the filter. For example, the filter 3948 caninclude an air permeable but fluid impermeable membrane. The filter 3948can be a hydrophobic filter. In some embodiments, the vial adapter 3908can include a check valve in place of or in addition to the filter 3948.The check valve could be a duck bill valve, a slit valve, or a slidingball valve, or any other suitable type of check valve. The vial adapter3908 can also have a bag that is configured to increase in volume whilepreventing the input air to contact the fluid inside the vial 3907,similar to the embodiments described in the '157 Publication. Thus, thevial 3907 can be vented by a mechanism independent of the connector3910.

FIG. 8 is a cross sectional view of the vial 3907 and vial adapter 3908in an assembled configuration. As shown by the flow lines in FIG. 8. Aircan pass through the filter 3948, through the air inlet channel 3946,and into the vial 3907 to compensate for the fluid that is drawn out ofthe vial 3907 through a fluid channel 3950. The fluid channel 3950 canpass through the spike 3942, and down through the female connector 3944as shown. Although the female connector 3944 is shown in a closedconfiguration in FIG. 8, it will be understood that the female connector3944 can be opened by the first male connector 3964 of the connector3910, as discussed below, to allow fluid to pass from the vial adapter3908 to the connector 3910.

FIG. 9 is a perspective view of the connector 3910. FIG. 10 is aperspective view of the connector taken from a different angle than theview of FIG. 9. The connector 3910 can have features similar to, or thesame as, those of the other connectors disclosed herein. The connector3910 can include an upper housing portion 3960 and a lower housingportion 3962. A first male connector 3964 can be attached to a femaleend 3966 of the upper housing portion. A second male connector 3968 canbe attached to a female end 3970 of the lower housing portions 3962. Themale connectors 3964, 3968 can be a version of the Spiros® closeablemale connector manufactured by ICU Medical, Inc., of San Clemente,Calif. Various embodiments of connectors of this type are described inthe '920 Publication. In this embodiment, and in other embodimentsdescribed herein as including a male connector or a female connector, itcan be possible for female connectors to be used in place of thedescribed male connectors and for male connectors to be used in place ofthe described female connectors. For example, one or both of theconnectors 3964 and 3968 can be female connectors (e.g., Clave®connectors manufactured by ICU Medical, Inc., of San Clemente, Calif.),and the connector 3944 of the Vial adapter 3908 can be a male connector(e.g., a Spiros® closeable male connector manufactured by ICU Medical,Inc., of San Clemente, Calif.).

A syringe interface 3972 can extend down from the bottom of the lowerhousing portion 3962 to receive the syringe 3912. A sensor region 3974can also be positioned at the base of the lower housing portion 3962 andcan be configured to allow light to pass through the fluid pathway inthe connector 3910 to detect the presence of bubbles, which can indicatethat the vial 3907 has run out of fluid. In some embodiments, thesurface of the sensor region can be flat to allow light to pass throughthe wall of the sensor region 3974 at an angle that is perpendicular tothe surface, thereby allowing the light to more reliably strike thecorresponding sensor. In some embodiments, the sensor region can be ator near the interface between the first male connector 3964 and theupper housing portion 3960, so that the bubble sensor can more easilydetect air before it reaches the syringe. For example, the female end3966 of the upper housing portion 3960 can be longer than shown in FIGS.9 and 10 and can be substantially transparent to light of the bubblesensor. In some embodiments, the walls of the female end 3966 can havegenerally flat sensor regions similar to 3974 discussed above.

In some embodiments, syringe interface 3972 can include a stopmechanism, such as a collar 3973, configured to control the position ofthe syringe 3912 relative to the connector 3910 when engaged. Forexample, as can be seen in FIGS. 13 and 14, the syringe 3912 can includea male luer tip 3915 and shroud 3913 surrounding the male luer tip 3915.When the syringe 3912 engages the syringe interface 3972 of theconnector 3910, the shroud 3913 can abut against the collar 3973 oncethe syringe 3912 is engaged to a desired position. Thus, the collar 3973can prevent the male luer tip 3915 from being over-inserted past thedesired engagement position. Other stop mechanisms can be used. Forexample, the connector 3910 can include a ridge formed on the inside ofthe syringe interface 3972 so that the male luer tip 3915 of the syringeabuts against the ridge when the syringe 3912 has reached the desiredengaged position.

The stop mechanism (e.g., collar 3973) can facilitate the alignment ofthe connector 3910, or other components, with one or more sensors (e.g.,air sensors and/or sensors configured to detect whether an IV bag isattached to the connector 3910). For example, in some embodiments, thebody of the syringe 3912 can engage with a mounting module 228 of thefluid transfer system 200 so that the syringe is secured to the system200. The connector 3910 can be secured to the system 200 indirectly bythe connector 3910 being engaged with the syringe 3912 via the syringeinterface 3972. Thus, if the syringe 3912 were over inserted past thedesired engagement position, the connector 3910 may be positioned lowerthan desired, which can interfere with the proper operation of thesensors. For example, an air sensor may be aligned with an incorrectportion of the connector 3910 causing the sensor to provide inaccuratereadings. In some embodiments, the connector 3910 can engage directlywith the mounting module 228 (e.g., using the protrusions 3961 a-binserted into corresponding grooves in the mounting module 228), and thestop mechanism can facilitate accurate transfer of fluid. For example,if the syringe 3912 were over-inserted past the desired position, anamount of extra fluid may be drawn into the syringe 3912 when theplunger is drawn back, thereby compromising the accuracy of the fluidtransfer, especially for fluid transfers that involve a volume thatrequire multiple syringe fills. Also, because the internal volume of thefluidics system may be less than the expected internal volume by a smallamount if the syringe is over-inserted, priming of the fluidics mayresult in pushing fluid into an IV bag prematurely.

In some embodiments, the connector 3910 can have features that areconfigured to secure the connector to a mounting module. For example,the connector 3910 can have one or more protrusions 3961 a-b that areconfigured to fit into corresponding slots in the mounting module. Theconnector 3910 may have slots configured to receive protrusions on themounting module. Many variations are possible. In the illustratedembodiment, the top housing portion 3960 has two extensions 3961 a-bthat extend past the sides of the bottom housing portion 3962 whenattached, thereby forming two protrusions. The protrusions may also, oralternatively, be formed on the lower housing portion 3962. Whenattached to a fluid transfer station (e.g., 218 a of FIG. 2), theprotrusions 3961 a-b of the connector 3910 can slide into correspondingslots to ensure that the connector 3910 is positioned at a locationwhere one or more sensors can align with corresponding portions of theconnector 3910 (or align with components attached to the connector3910), as described herein. Also, the slots or protrusions or otherfeatures on the mounting module can be configured to interface only withconnectors having corresponding features (e.g., protrusions 3961 a-b) toverify that the connector 3910 is compatible or approved for use withthe system. This can prevent a user from using a connector withinsufficient leak-prevention features or a connector with a differentinternal volume (which can interfere with the precision of the transferof fluid).

FIG. 11 is an exploded perspective view of the connector 3910. FIG. 12is an exploded perspective view of the connector 3910 taken from adifferent view than FIG. 11. The first male connector 3964 can beconfigured to engage the connector 3944 of the vial adapter 3908. Thus,when the vial 3907 runs out of fluid, the vial 3907 and vial adapter3908 can be replaced without replacing the connector 3910, syringe 3912,or any other part of the fluidics assembly 3906. This can provide thebenefit of reducing the amount of disposable pieces and fluid sent towaste during a vial replacement.

When the vial 3907, vial adapter 3908, connector 3910, syringe 3912, andIV bag assembly 3914 are connected, a source fluid pathway can be formedbetween the vial 3907 and the syringe 3912, and a target fluid pathwaycan be formed between the syringe 3912 and the IV bag. A source checkvalve 3976 can be positioned in the source fluid pathway (e.g., insidethe connector 3910) to allow fluid to flow from the vial 3907 into thesyringe and prevent fluid from flowing back into the vial 3907. A targetcheck valve 3978 can be positioned in the target fluid pathway (e.g.,inside the connector 3910) to allow fluid to flow from the syringe 3912to the IV bag and prevent fluid from flowing from the IV bag back towardthe syringe 3912. The source and target check valves 3976, 3978 can beduck bill check valves, although dome check valves, disc check valves,or any other suitable check valve can be used. In some embodiments, thesource and target check valves 3976, 3978 can be integrated into asingle valve structure such as a flap movable between a source flowposition in which fluid may flow through the source fluid path into thesyringe 3912 and a target flow position in which fluid may flow throughthe target fluid path from the syringe 3912.

FIG. 13 is a cross sectional view of the connector 3910 and syringe 3912showing fluid flowing through the connector 3910 from the vial 3907 tothe syringe 3912. As the plunger of the syringe 3912 is withdrawn, fluidis drawn into the syringe 3912. The pressure causes the source checkvalve 3976 to open so that fluid is allowed to flow from the vial 3907to the syringe 3912. The pressure also causes the sides of the targetcheck valve 3978 to bear against each other to maintain the target checkvalve 3978 closed. Thus, fluid drawn into the syringe 3912 will be drawnfrom the vial 3907 and not the IV bag. As fluid is drawn out of the vial3907, air can enter the vial 3907 through the air inlet channel 3946 asdescribed above in connection with FIG. 8.

FIG. 14 is a cross sectional view of the connector 3910 and syringe 3912showing fluid flowing through the connector 3910 from the syringe 3912toward the IV bag assembly 3914. As the plunger of the syringe 3912 isadvanced, fluid is driven out of the syringe 3912. The pressure causesthe target check valve 3978 to open so that fluid is allowed to flowfrom the syringe 3912 toward the IV bag assembly 3914. The pressure alsocauses the sides of the source check valve 3976 to bear against eachother to maintain the source check valve 3976 closed. Thus, fluid drivenout the syringe 3912 will be directed to the IV bag and not back intothe vial 3907.

FIG. 15 is a perspective view of the IV bag assembly 3914. The IV bagassembly 3914 can include an IV bag 3980, a length of tubing 3982, and afemale connector 3984. The female connector 3984 can be removably orirremovably attached to the tubing 3982. The female connector 3984 canfunction to seal off the IV bag assembly 3914 so that no fluid canescape from the IV bag 3980 except when a male connector is attachedthereto. In some embodiments, the IV bag assembly 3914 can include asupplemental line of tubing 3925 to also provide access to the IV bag3980. The supplemental line 3925 can be used to transfer a second fluid(which can be different than the fluid transferred through the main line3982) into the IV bag 3980. For example, the tubing 3984 can be used totransfer a concentrated fluid (e.g., medication) into the IV bag 3980,and the supplemental tubing 3925 can be used to transfer a diluent(e.g., saline or water) into the IV bag 3980 for diluting theconcentrated fluid to a desired level of concentration. In someembodiments, the supplemental line of tubing 3925 can have a cap or aconnector (not shown), which can be similar to the connector 3984, toenable a fluid line to be removably attached to the supplemental line3925. In some embodiments, multiple fluid lines can combine (e.g., at aY- or T-connection) so that multiple fluids (e.g., from different fluidtransfer stations) can be directed into the IV bag 3980 through a singlefluid line (e.g., tubing 3982). In some embodiments, the connector 3984can be directly coupled with the bag 3980 without a significant lengthof tubing 3982 therebetween.

FIG. 16 is an alternative IV bag assembly 5700 which may be used withthe fluidics assembly 3906 or with various other embodiments discussedherein. The IV bag assembly 5700 can include an IV bag 5702 and a lengthof tubing attached thereto 5704. A spike port 5706 can be positioned atthe end of the tubing 5704, and the spike port 5706 can include apiercing membrane or barrier that when closed prevents fluid fromentering or exiting the IV bag 5702. The female connector 5708 can havea spike 5710 attached thereto. The spike 5710 can be inserted into thespike port 5706 until it pierces the membrane or barrier therebyproviding access to the interior of the IV bag 5702. In someembodiments, the part 5706 is directly coupled with the bag 5702 withouta significant length of tubing 5704 therebetween.

FIG. 17 shows a perspective view of a connector 338 which can be used asthe source connector portion 3964 and/or the target connector portion3968 of the connector 3910. FIG. 18 shows a top view of a housingportion of the connector 338. FIG. 19 is an exploded perspective view ofthe connector 338. FIG. 20 shows a cross-sectional view of the connector338 and a female connector 332 in an unengaged configuration. FIG. 21shows a cross-sectional view of the connector 338 and the femaleconnector 332 in an engaged configuration. Although the connector 338 isshown separated from the remainder of the connector 3910 in FIGS. 17-21,it should be understood that the connector 338 can be connected to theremainder of the connector 3910 when in use.

With reference now to FIGS. 17-21, the connector 338 can be a closeablemale luer connector that is configured to prevent fluid from escapingfrom or entering into the connector when it is not engaged with acorresponding female connector, but allow fluid to flow when it isengaged with a corresponding female connector 332. In the embodimentsshown, the connector 338 can be a version of the Spiros® closeable maleconnector manufactured by ICU Medical, Inc., of San Clemente, Calif. Insome embodiments, a substantially entirely or entirely closed system canbe achieved, at least in part, by providing corresponding automaticallycloseable male and female connectors at various (or all) connectionpoints within the fluid transfer system 200, thereby causing thestationary fluid to substantially entirely remain within the fluidsource, the fluid module, and the fluid target, respectively, upondisconnection and to not generally leak or vaporize outside of thesystem. For example, in some embodiments, corresponding pairs ofautomatically closing connectors (e.g., male and female connectors) canbe provided at the interfaces between the fluid source and the connector3910, the connector 3910 and the intermediate container, and/or theconnector and the target container.

The closable male connector 338 can include a housing 398, a valvemember 400, a resilient member 402, a sealing ring 404, an end cap 406,and an O-ring 407. The housing 398 can be generally tubular in shape,and can include a passageway 408 that extends axially through thehousing 398. As illustrated, the passageway 408 includes apertures oneach side of the connector. The housing 398 can include a male luer tip410 that connects to the rest of the housing 398 at a base 412. The luertip 410 can be generally tubular in shape so that a portion of thepassageway 408 is defined therein, and the luer tip 410 can include ahole 414 at its end providing access to the passageway 408. In someembodiments, the luer tip 410 includes a shelf 416 that extends radiallyinwardly toward the axis of the passageway 408. The shelf 416 can belocated adjacent to the hole 414, so that the passageway 408 is narrowedat the end of the luer tip 410. In some embodiments, the surface of theshelf 416 that faces radially inwardly is tapered so that the passageway408 is narrowest immediately adjacent to the hole 414. In somecircumstances, the shelf 416 can be configured to seal the passagewaywhen a portion of the valve member 400 is abutted against it. Asillustrated, in some embodiments, connectors can be used tosubstantially entirely prevent fluid therein to leak or otherwise escapethrough apertures in the fluid pathway when the connectors are closed.

The luer tip 410 can be surrounded by a shroud 418. In some embodiments,the luer tip 410 extends some distance beyond the edge 420 of theshroud. The shroud 418 can include inner threads 422 on its interiorsurface. The inner threads 422 can be used for securing a femaleconnector 332. The shroud can include an indented portion 424 that has asmaller outer diameter than the other portions of the housing. Theindented portion 424 can be configured to engage a portion of theresilient member 402.

The housing 398 can include two wall sections 426 a, 426 b separated bytwo gaps 428 a, 428 b. The gaps 428 a, 428 b can be configured toreceive portions of the resilient member 402. The wall sections 426 a,426 b can be configured to engage the end cap 406.

In some embodiments, the housing 398 includes a middle portion 430located substantially between the wall sections 426 a, 426 b, andconnected to the wall sections 426 a, 426 b near the gaps 428 a, 428 b.In some embodiments, holes 432 a, 432 b are defined between the middleportion 430 and the wall sections 426 a, 426 b (as shown in FIG. 18). Insome embodiments, the luer tip 410 connects to the middle portion 430 atits base 412. In some embodiments, the middle portion 430 defines aportion of the passageway 408 therein. In some embodiments, portions 434of the outer surface of the middle portion 430 are exposed by the gaps428 a, 428 b. The portions 434 can include notches 436 a, 436 b andthrough-holes 438 a, 438 b. The notches 436 a, 436 b can be generallyrectangular in shape, and can be tapered such that the notches 436 a,436 b are narrower near their bases than near their surfaces. Thethrough-holes 438 a, 438 b can also be generally rectangular in shape.

The housing 398 can be constructed from a variety of materials. Thehousing 398 can be constructed from a rigid material such aspolycarbonate or other polymeric materials. In some embodiments, thehousing 398 can be constructed from a hydrophobic material such as BayerMakrolon, or any other suitable material. In some embodiments, thehousing 398 can be formed from a substantially transparent material.

The valve member 400 can include a fluid passageway 440 extendingaxially from an opening formed in a base portion 444 and into a tube446. In some embodiments, the passageway 440 can be wider in the baseportion 444 than in the tube 446. In some embodiments, the tube 446includes a narrowed tip 448. In some embodiments, the tip 448 can have atapered outer surface. The tip 448 can be tapered to substantially thesame degree as the radially inwardly facing surface of the shelf 416 andcan be sized so that the tip 448 can form a fluid seal with the shelf416 when abutted against it. In some embodiments, the tip 448 can bemade from a flexible or compressible material, such as silicone rubberto facilitate formation of the fluid seal between the tip 448 and theshelf 416. In some embodiments, the tube can include one or more holes450 for providing access to the fluid passageway 440. The holes 450 canbe formed, for example, in the tip 448 of the tube 446.

In some embodiments, the valve member 400 can include two struts 452 a,452 b extending out from the base 444 and positioned on either side oftube 446, so that an open space is defined on either side of the tube.In some embodiments, the tube 446 can extend axially past the ends ofthe struts 452 a, 452 b.

The base 444 of the valve member 400 can include a plurality ofprotrusions 454 extending radially outwardly from its external surface.In some embodiments, the protrusions 454 can be positioned so as todefine two channels 456 a, 456 b therebetween. In some embodiments, theprotrusions 454 do not extend across the full length of the base 444,leaving a lower portion 458 of the base 444 that has a substantiallysmooth outer surface.

The valve member 400 can be constructed from a variety of materials,such as polycarbonate or other polymeric materials. In some embodiments,the valve member 400 can be constructed from the same material as thehousing 398. In some embodiments, the valve member 400 and housing 398can be constructed from different materials. In some embodiments, thevalve member 400 can be constructed from multiple materials or frommultiple pieces. For example, the tip 448 can be constructed from amaterial that is more flexible than the remainder of the valve member400. In some embodiments, the valve member 400 can be formed from asubstantially opaque material.

The resilient member 402 can include a first ring 460 and a second ring462 connected to each other by elastic members 464 a, 464 b. The elasticmembers 464 a, 464 b can be made from an elastic material that exerts arestoring force when stretched, such as silicon rubber. Thus, if therings 460, 462 are pulled apart, the elastic members 464 a, 464 bfunction to restore the rings 460, 462 to their relaxed configuration.In some embodiments, the rings 460, 462 are also constructed from anelastic material, such as the same material used to form the elasticmembers 464 a, 464 b. In some embodiments, the second ring 462 can havea greater diameter than the first ring 460. In some embodiments, thesecond ring 462 can have a tapered outer surface so that the end of thesecond ring 462 that is closest to the first ring 460 is wider than theend of the second ring 462 that is furthest from the first ring 460.

The sealing ring 404 can be generally cylindrical in shape, and can havea bore 466 extending axially therethrough. The sealing ring 404 can havea cylindrical body section 468 and an O-ring 470 located at one end ofthe body section 468. In some embodiments, the thickest portion of theO-ring 470 can be thicker than the body section 468 so that the thickestportion of the O-ring 470 extends radially inwardly toward the axis ofthe bore 466 a distance past the inner surface of the body section 468.Thus, the bore 466 can be narrower at the thickest part of the O-ring470 than in the body section 468. In some embodiments, the thickestportion of the O-ring 470 also extends radially outwardly a distancepast the outer surface of the body section 468. The sealing ring 404 caninclude two protrusions 472 a, 472 b that extend radially outwardly fromthe body section 468. In some embodiments, the protrusions 472 a, 472 bcan be generally rectangular in shape.

The sealing ring 404 can be constructed from a variety of materials. Insome embodiments, the sealing ring 404 can be constructed from adeformable or elastic material such as a silicone rubber. In someembodiments, the sealing ring 404 can be constructed from the samematerial used for form the resilient member 402. In some embodiments,the sealing ring 404 can be constructed from a material capable offorming a fluid seal against a rigid plastic or other rigid polymericmaterial.

The end cap 406 can include a first end cap member 405 and a second endcap member 409. The second end cap member 409 can include a connector(e.g., a male connector 352), a plunger 474, and a disk portion 476located between the male connector 352 and the plunger 474. The secondend cap member 409 can have a fluid passageway 478 axially positionedtherein. In some embodiments, the plunger 474 can be generally tubularin shape. In some embodiments, the outer surface of the plunger 474includes an indented region 480, which can be configured to receive theO-ring 407 therein. The O-ring 407 can be constructed from an elasticmaterial such as silicone rubber so that it can be stretched over theedge 482 of the plunger 474 and be seated in the indented region 480. Insome embodiments, the O-ring 407 can be constructed from the samematerial as the resilient member 402 and/or the sealing ring 404. Insome embodiments, the O-ring 407 can be sized so that when seated in theindented region 480, the thickest portion of the O-ring 407 extendsradially outwardly a distance past the outer surface of the plunger 474.

In some embodiments, the passageway 478 can have a substantiallyconstant width throughout the second end cap member 409. In someembodiments, the passageway 478 can be tapered so that it is wider inthe male connector 352 than in the plunger 474. In some embodiments, thepassageway 478 can narrow near the end of the plunger 474, for example,to accommodate the indented region 480.

The first end cap member 405 can be generally frustoconical in shape andcan have a central opening 471 therein. When assembled, the plunger 474can extend through the central opening 471. A ridge 473 can extendinward into the central opening 471. The ridge 473 can be received intoa channel 475 on the second end cap member 409, which can, for example,be formed between the base of the plunger 474 and the disk portion 476on the second end cap member 409, to secure the first end cap member 405to the second end cap member 409. The ridge 473 and correspondingchannel 475 can allow the first end cap member 405 to rotate about alongitudinal axis with respect to the second end cap member 409. Thus,the first end cap member 405 and the second end cap member 409 can jointo form the end cap 406.

The valve end cap 406 can be constructed from a variety of materials,such as polycarbonate or other rigid polymeric materials. In someembodiments, the end cap 406 can be constructed from the same materialas the housing 398 and/or the valve member 400. In some embodiments, theend cap 406 can be constructed from a different material than the valvemember 400 and/or the housing 398. The first end cap member 405 can beformed from the same material as the second end cap member 409, ordifferent materials can be used. In some embodiments, the first end capmember 405 or the second end cap member 409 or both can be substantiallytransparent.

Certain interconnections between various parts of the male connector 338will now be discussed in further detail. The sealing ring 404 can bepositioned inside the middle portion 430 of the housing 398. Theprotrusions 472 a, 472 b can be sized and positioned so that they engagethe through-holes 438 a, 438 b. Thus, the sealing ring 404 can besecured to the housing 398 so that it does not rotate or move axiallywith respect to the tube 446.

The valve member 400 can be slidably inserted into the housing 398 sothat the tube 446 enters the passageway 408. The narrowed tip 448 of thetube 446 can pass through the bore 466 of the sealing ring 404 and intothe male luer tip 410 until it abuts against the shelf 416. The tube 446can have a width that substantially fills the bore 446 and pressesagainst the O-ring 470 portion of the sealing ring 404 to form a fluidseal therebetween. The struts 452 a, 452 b can pass through the holes432 a, 432 b in the housing 398 respectively, so that the struts 452 a,452 b are positioned between the male luer tip 410 and the shroud 418.

The resilient member 402 can function to bias the valve member 400against the housing 398. The first ring 460 can fit onto the lowerportion 458 of the base 444 of the valve member 400, so that a surfaceof the ring 460 abuts against the protrusions 454. The second ring 462can fit into the indented portion 424 of the housing. The elasticmembers 464 a, 464 b can be positioned in the channels 456 a, 456 brespectively, and can pass through the respective gaps 428 a, 428 bbetween the wall sections 426 a, 426 b of the housing 398.

The O-ring 407 can be seated onto the indented region 480 of the end cap406, as discussed above, and the plunger 474 can be slidably inserted atleast partially into the passageway 440 of the valve member. In someembodiments, the thickest portion of the O-ring 407 can be wider thanthe portion of the passageway 440 formed in the base 444 of the valvemember 400, so that the O-ring 407 forms a fluid seal against the innersurface of the passageway 440. The plunger 474 can be inserted into thevalve member 400 until the disk portion 476 of the end cap 406 comesinto contact with the ends of the wall sections 426 a, 426 b of thehousing 398.

In some embodiments, the wall sections 426 a, 426 b can be secured tothe top surface 477 of the first end cap member 405 by sonic welding,snap fit structures (not shown), a pressure or friction fitting, orother suitable connection type. As mentioned above, the first end capmember 405 can be secured to the second end cap member 409 in a mannerthat allows the first end cap member 405 to rotate relative to thesecond end cap member 409. Thus, once the connector 338 is assembled,the housing 398, sealing ring 404, resilient member 402, valve member400, and/or first end cap member 405 can rotate relative to the secondend cap member 409 about the longitudinal axis. Many variations arepossible. For example, in some embodiments, the connector 338 caninclude a frangible element (not shown) that is configured to preventthe housing 398 and/or other components from rotating relative to thesecond end cap member 409 until a sufficient force is applied to breakthe frangible element. Once the frangible element is broken, such as byrotating the housing 398 or other component of the connector 338 withsufficient force, the housing 398 and/or other components can bepermitted to rotate relative to the second end cap member 409, asdescribed in the '920 Publication. In some embodiments, no frangibleelement is included, and the housing 398 and/or other components of theconnector 338 can be rotatable relative to the second end cap member 409once the connector 338 is assembled.

With reference now to FIGS. 20-21, the connector 338 can be configuredto engage a female connector 332. A variety of types of femaleconnectors 332 can be used. The female connector 332 shown is a closablefemale luer connector that includes a housing 490, a spike 492, a base494, and a resilient seal element 496. A fluid passageway 498 can passthrough the base 494 and through the spike 492. The spike 492 caninclude one or more holes 500 providing fluid communication between thepassageway 498 and the area outside the spike 492. The seal element 496can be shaped and positioned to substantially surround the spike 492.The seal element 496 can include a closable aperture 502 or slit thatcan open to allow the tip of the spike 492 to pass through then end ofthe seal element 496 when the seal element 496 is compressed (as shownin FIG. 21). The housing can include external threads 504 configured toengage the inner threads 422 on the housing 398 of the connector 338. Anend of the tubing 334 can be connected to the end of the femaleconnector 332 by an adhesive, clamp, friction or pressure fitting, orother suitable manner to form a fluid tight connection.

As discussed above, in some embodiments, the housing 398, sealing ring404, resilient member 402, valve member 400, and/or first end cap member405 can rotate about the longitudinal axis with respect to the secondend cap member 409. Thus, as the female connector 332 of the IV bagassembly is attached to the connector 338, the female connector 332 canbe held still while the housing 398 of the connector 338 can rotatecausing the threads 504, 422 to engage. Because the female connector 322is not required to rotate during engagement and disengagement with theconnector 338, the tubing 334 can avoid being twisted or kinked and theuser is not required to twist the IV Bag to accommodate rotation of thefemale connector 322. Some additional embodiments of the connectors withthis rotational capability are disclosed in the '920 Publication.

When not engaged with the female connector 332 (as shown in FIG. 20),the connector 338 can be sealed. In some embodiments, fluid can enterthe connector 338 at the male connector 352 and pass through thepassageway 478 of the end cap 406, through the passageway 440 of thevalve member 400, through the holes 450, and into the portion of thepassageway 408 defined by the male luer tip 410. But the fluid sealcreated by the tip 448 of the valve member 400 pressing against theshelf 416 of the male luer tip 410 prevents the fluid from exiting theconnector 338. In some embodiments, an increase in pressure, such aswhen additional fluid is forced into the connector 338, causes the tip448 to press more firmly against the shelf 416, thereby improving thefluid seal.

When the connector 338 is engaged with the female connector 332 (asshown in FIG. 21), the external threads 504 of the female luer connector332 can engage the inner threads 422 on the shroud 418, securing thefemale connector 332 to the male connector 338. The edge of the maleluer tip 410 can press against and compress the resilient seal element496 so that the spike 492 passes through the aperture 502 until theholes 500 are exposed. The end of the housing 490 of the female luerconnector 332 can enter the space between the male luer tip 410 and theshroud 418 until it contacts the struts 452 a, 452 b. As the female luerconnector 332 further engages the connector 338, it can push on thestruts 452 a, 452 b causing the entire valve member 400 to retract. Asthe valve member 400 retracts, the elastic members 464 a, 464 b of theresilient member 402 stretch. When the valve member 400 retracts, thetip 448 disengages from the shelf 416, breaking the fluid seal andallowing fluid pass from the passageway 408 in the housing 398 of theconnector 338 to the passageway 498 in the female connector 332 via theholes 500. When engaged, the resilient seal element 496 exerts arestoring force toward the connector 338 that presses the end of theseal element 496 against the end of the male luer tip 410, forming afluid seal therebetween. Thus, the fluid can be kept isolated from theexternal environment while it is transferred from the male connector 338to the female connector 332.

The female connector 332 can be disengaged from the male connector 338.The restoring force exerted by the resilient seal element 496 of thefemale connector 332 causes it to return to its closed position, sealingoff its passageway 498. The elastic members 464 a, 464 b of theresilient member 402 exert a restoring force on the valve member 400,causing the valve member 400 to return to its closed position with itstip 448 abutted against the shelf 416 as the female connector 332 isdisengaged.

The '920 Publication discloses additional details and variousalternatives that can be applied to the connector portion 338 of theconnector 320.

FIG. 22 illustrates the transfer station 218 a with a connector 226 anda syringe 222 secured thereto by the mounting module 228 a. The mountingmodule 228 a can include an upper mounting portion 254 and a lowermounting portion 256. In the illustrated embodiment, the upper mountingportion 254 can be configured to receive the connector 226 and/or anupper portion of the syringe 222, and/or the lower mounting portion 256can be configured to receive a lower portion of the syringe 222, such asa flange of the syringe body. An actuator 258 can engage the plunger ofthe syringe 222 (e.g., by a plunger flange), and the actuator 258 can bedriven by a motor (e.g., step motor) so that the actuator 258 moves withrespect to the lower mounting portion 256. By moving the actuator 258downwardly, away from the lower mounting portion 256, the plunger can bewithdrawn to draw fluid into the syringe 222. By moving the actuator 258upwardly, towards the lower mounting portion 256, the plunger can drivethe fluid out of the syringe 222.

The upper mounting portion 254 can be similar to, or the same as, theupper mounting portions described in the '703 Publication. The uppermounting portion 254 can include a base member 260 and a cassette 262,which can be removable from the base member 260 in some embodiments. Thebase member 260 can be coupled to the housing 202 and can have holes orchannels to allow wires to pass from the housing 202 through the basemember 260 to the cassette 262. The wires can provide electricity forsensors and can carry signals to and from the sensors as describedherein. The base member 260 can include two arms 264 a-b that form arecess therebetween to receive the cassette 262. One of the arms 264 bcan have a hole 266 which can be configured to receive a shaft forsupporting an IV bag or other container as discussed herein. The '703describes many details and variations that can be applied to the uppermounting portion 254 or to the other features of the mounting module 228a.

FIG. 23 is a perspective view of the cassette 262. The cassette 262 caninclude two arms 268 a-b forming a recess therebetween that can beconfigured to receive the connector 226. In some embodiments, thecassette 262 can include one or more features that are configured toengage with corresponding features on the connector 226 a. For example,one or both of the arms 268 a-b can have grooves 270 a-b configured toreceive the projections 3961 a-b of the connector 226 as the connector226 a slides into the recess between the arms 268 a-b. The engagementbetween the connector 226 a (e.g., projections 3961 a-b) and thecassette 262 (e.g., the grooves 270 a-b) can secure the connector 226 arelative to the cassette 262 at a location that aligns one or moresensors on the cassette 262 with portions of the connector 226 aconfigured to interface with or be compatible with the sensors. Theinterface between the grooves 270 a-b and the projections 3961 a-b canalso prevent the connector 226 a from rocking or shifting in positionduring use.

Channels 272 can be formed in the cassette 262 to provide pathways forwires to connect to sensors. The cassette 262 can include one or moresensors configured to detect air in the fluid pathway from the sourcecontainer (e.g., vial 220) into the connector 226 a. In someembodiments, the one or more air sensors can detect whether air ispresent in the sensor path by using light, e.g., by measuring the amountof light that is transmitted, absorbed, scattered, or otherwise affectedby the material that the light propagates through. In some cases,multiple sensors can be combined to use different wavelengths of light,e.g., for use with different types of fluid.

FIG. 24 is a semi-transparent view of an example embodiment of acassette 262 with sensors incorporated therein. In the embodiment ofFIG. 24, the cassette 262 can include a first light source 274 a of afirst type and a second light source 274 b of a second type. Thecassette 262 can also include a first light detector 276 a configured todetect light of the first type and a second light detector 276 bconfigured to detect light of the second type. In some embodiments, thefirst light source 274 a and the first light detector 276 a can beconfigured to use visible red light to detect air (e.g., bubbles) inalcoholic fluids. The light used by the light source 274 a and detector276 a can have a wavelength of at least about 620 nm and/or less than orequal to about 750 nm, or of at least about 640 nm and/or less than orequal to about 650 nm, or of about 645 nm, although other colors oflight, and even non-visible light, can be used. The light used by thelight source 274 b and the detector 276 b can use infrared light (e.g.,near-infrared, short-wavelength infrared, or infrared-B) to detect air(e.g., bubbles) in non-alcoholic fluids. The light used by the secondlight source 274 b and the second detector 276 b can use infrared lighthaving a wavelength of at least about 1250 nm and or less or equal toabout 1650 nm, or of at least about 1400 nm and/or less than or equal toabout 1500 nm, or of about 1450 nm, although light of other wavelengthsmay also be used.

In the illustrated embodiment, the air sensors can be configured so thatthe light paths for the two air sensors 274 a-b, 276 a-b cross oroverlap. In some embodiments, the light paths do not cross and can besubstantially parallel to each other. FIG. 25 is a cross sectional viewof the connector 226 a showing the location 278 where the light passesthrough the connector 226 a for air detection. The location 278 can bewhere the light paths cross. In some embodiments, the light can passthrough the interface between the connector body 282 and the sourceconnector portion 284 that leads to the fluid source vial (not shown).For example, the light can pass through a source connector projection286 (e.g., a female fitting) that extends from the connector body 282 toreceive a connection portion 288 (e.g., a male fitting) of the sourceconnector 284. The light can pass through an area 280 between the tip ofthe connection portion 288 of the source connector 284 and the connectorbody 282, so that the light does not pass through the connection portion288 of the source connector 284. Many alternatives are possible. Forexample, one or more of the light paths can pass through the connectionportion 288 of the source connector 284 instead of the source projection286. Thus, the source projection 286 can be shorter than shown in FIG.25 and the connection portion 288 of the source connector 284 can belonger than shown in FIG. 25, so that the area 280 corresponds to theportion of the connector portion 288 that is positioned above the sourceprojection 286. Alternatively, the one or more of the light paths canpass through both the source projection 286 and the connector portion288 of the source connector 284. Also, the locations of the lightsources 274 a-b and the detectors 276 a-b can be interchanged. Also, thesensors may be positioned so that the light passes through a differentportion of the connector 226 a, such as the area of the connector body282 that is above the syringe 222.

The source projection 286 can be curved (e.g., having a circular crosssectional shape) and the crossing light paths can allow each path oflight to intersect the walls of the curved source connector projection286 at an angle that is normal or substantially normal (e.g., plus orminus 20°, 10°, 5°, 2°, or 1°) to the surfaces of the walls, as can beseen, for example, in FIG. 26, which can reduce the amount of light thatis reflected or otherwise lost as the light propagates through the wallsof the source connector projection 286. The two light paths can bepositioned at substantially the same vertical position so that an airbubble traveling towards the connector 226 a contacts both light pathssubstantially simultaneously. Thus, the system can treat air bubbledetection the same in some ways regardless of which of the detectors 276a-b identified the air bubble. If one detector 276 a-b were positionedvertically above the other, and the flow of fluid is stopped upondetection of a bubble, the detected bubble may be positioned at adifferent location depending on which detector 276 a-b identified thebubble, which may be undesirable. Locating the light sources 274 a-b anddetectors 276 a-b in substantially the same horizontal plane can alsoresult in a more compact connector as compared to a configuration inwhich the sensors are positioned at different vertical positions.

The cassette 262 can also include one or more sensors for detectingwhether an IV bag, or other target container, is attached to theconnector 226 a. In some embodiments, the system 200 can disable fluidtransfer (e.g., by not allowing the motor to advance the plunger of thesyringe 222) if no target container is attached to the connector 226 a,thereby preventing unintentional discharge of fluid from the connector226 a. The sensors can be similar to, or the same as, the correspondingsensors described in the '703 Publication. The one or more sensors canuse light to detect whether a valve of the target connector 294 is openor closed, and the system can allow transfer of fluid only when thevalve is determined to be open. For example, one or more beams of lightcan be transmitted through the target connector 294 at a location wherethe target connector 294 is transparent in the closed position (e.g.,through a transparent portion of the housing), and when the valve of thetarget connector 294 is opened, an opaque portion of the targetconnector 294 can be moved to block the beam of light, therebyindicating that an IV bag or other target container is attached to thetarget connector 294.

The cassette 262 can include two light sources 290 a-b and twocorresponding light detectors 292 a-b. The system can be configured toallow the transfer of fluid only when both beams of light are blockedfrom reaching the corresponding detectors 292 a-b. Thus, if light forone detector (e.g., 292 a) is unintentionally blocked or otherwisediverted away from the detector (e.g., 292 a) when no IV bag isattached, the system will continue to prevent fluid from being expelledfrom the syringe 222 if the other detector (e.g., 292 b) detects lightfrom the corresponding light source 290 b. FIG. 27 is a cross sectionalview of the target connector 294 portion of the connector 226 showingthe light paths between the light sources 290 a-b and the detectors 292a-b. In some embodiments, features of the target connector 294 (e.g.,edges 296 of the housing 298) can interfere with the light beams when atcertain orientations. For example, as the housing 298 rotates, the edges296 may be positioned so that light from the light sources 290 a-b is bereflected by the edges 296, or can be diverted by or trapped in thehousing 298 (e.g., by total internal reflection). The light sources 290a-b and detectors 292 a-b can be positioned so that when the valve isclosed (e.g., no IV bag attached) and when a disrupting featureinterferes with light from on light source (e.g., 290 a), the light fromthe other light source (e.g., 290 b) can be aligned to pass through thetarget connector 294 with low enough disruption to trigger thecorresponding detector (e.g., 292 b).

In some embodiments, the light sources 290 a-b and the detectors 292 a-bcan be aligned on substantially the same vertical plane, which canresult in a more compact connector than if the sensors were positionedat different horizontal positions. The light beams can be angled so thatthey intersect the surfaces of the walls of the target connector 294 atan angle that is normal, or substantially normal (e.g., plus or minus20°, 10°, 5°, 2°, or) 1° to the surfaces, thereby reducing theoccurrence of unintentional (e.g., when no IV bag is attached) divertingof light away from the detectors 292 a-b (e.g., by reflection,refraction, total internal reflection). The light used by the lightsources 290 a-b and the detectors 292 a-b can use infrared light (e.g.,near-infrared light) having a wavelength of at least about 800 nm and orless or equal to about 960 nm, or of at least about 860 nm and/or lessthan or equal to 900 nm, or of about 880 nm, although light of otherwavelengths may also be used.

Many variations are possible. For example, the sensors can be arrangedso that light from the one or more light sources 290 a-b is permitted toreach the one or more detectors 292 a-b when the valve of the targetconnector 294 is open, and so that the light is blocked when the valveis closed. Also, in some embodiments, a single light source andcorresponding detector can be used to detect whether the valve of thetarget connector 294 is open or closed. In some embodiments, one or moreoptical sensors can be positioned so that the IV bag itself, or othercomponent associated with the IV bag (e.g., a female connector), blocksthe sensor light when the IV bag is attached.

FIG. 28 illustrates an example transfer station 218 a with a tray 300attached to the base member 260 of the upper mounting portion 254. Thetray 300 can be attached to a shaft 302, which can be inserted into thehole 266 in the base member 260. The tray 300 can be configured tosupport the IV bag (not shown in FIG. 28). Additional details andvariation relating to the tray 300, and the rest of the transfer station218, are described in the '703 Publication.

In some embodiments, the IV bag 224 a can be hung facing downward, asshown in FIG. 2. In the hanging configuration, the IV bag 224 a can belocated closer to the transfer station 218 a (and to the housing 202)than when using a tray 300, as shown in FIG. 28. Thus, the hangingconfiguration can provide a more compact system. Also, as the IV bag 224a is filled with fluid, the weight of the fluid can shift the center ofgravity of the system. In some embodiments, the weight of the housing202 can prevent the system 200 from tipping as the center of gravitymoves towards the IV bag 224 a. In some embodiments, a foot member (notshown) can extend from the bottom of the housing 202 to prevent thesystem 200 from tipping. Because the hanging IV bag configuration (FIG.2) can position the IV bag 224 a closer to the housing 202 than when thetray 300 is used (FIG. 28), the center of gravity can remain closer tothe center of the housing as the IV bag 224 a fills when the IV bag 224a is in the handing configuration. Thus, the hanging bag configurationcan increase the stability of the system 200, which can allow for a morelight weight housing 202 to be used.

In some embodiments, the fluid pathway leading from the connector 226 ato the IV bag 224 a is not linear, and can include a turn downwardtowards the IV bag 224 a. The turn in the fluid pathway can be at leastabout 60° and/or less than or equal to about 120°, or about 90°. A firstportion of the fluid pathway (e.g., connected to the connector 226 a)can extend substantially horizontally (e.g., plus or minus 30°, 15°, 5°,or less), and a second fluid pathway (e.g., connected to the IV bag 224a) can extend substantially vertically (e.g., plus or minus 30°, 15°,5°, or less).

FIG. 29 illustrates an example embodiment of an attachment 304configured to hang an IV bag downward. FIG. 30 shows an IV bag 224suspended in a substantially vertical hanging configuration by theattachment 304. FIG. 31 shows the attachment 304 and IV bag assemblyremoved from the rest of the system. The attachment 304 can include afirst side 306 and a second side 308 with a gap 310 formed therebetween.An extension 312 can extend across the gap 310 to connect the first side306 to the second side 308. The attachment 304 can include a hole 314configured to receive a shaft 316 (which can be similar to, but shorterthan, the shaft 302 of FIG. 28). A threaded bore 318 can extend throughthe attachment 304 at an angle transverse to the hole 314, and thethreaded bore 318 can receive a thumb screw 320 that can be tightened toengage the shaft 316 to secure the attachment 304 to the shaft 316. Insome embodiments, the shaft 316 can include a groove or hole configuredto receive the end of the thumb screw 320 to prevent the attachment 304from rotating about the shaft 316. Other quick release mechanisms can beincorporated to secure the shaft 316 to the attachment 304. In someembodiments, the shaft 316 can have a square, or other non-circular,cross sectional shape to prevent the attachment 304 from rotating aboutthe shaft 316. The attachment 304 can be attached to the shaft 316 sothat a front side 328 of the attachment 304 faces away from the transferstation 218 and so that a back side 330 of the attachment 304 facestowards the transfer station 218.

The attachment 304 can include one or more features (e.g., grooves 322a-b) configured to support the IV bag 224. The IV bag 224 can beattached to a support member 324 configured to engage the attachment304. The support member 324 can have features (e.g., flange 326)configured to engage the corresponding features (e.g., grooves 322 a-b)of the attachment 304 to removably attach the support member 324 to theattachment 304. Other manners of engagement between the support member324 and attachment 304 are possible. For example, protrusions on theattachment 304 can engage grooves in the support member 324. Theinterface between the attachment 304 and support member 324 can bestrong enough to support the weight of the IV bag 224 when containingfluid.

The support member 324 can have a fluid path to provide communicationbetween the IV bag 224 and a connector 226. A connector 332 (e.g., afemale connector such as a Clave® connector) can be attached to thesupport member 324 and can be configured to removably engage acorresponding connection portion of the connector 226 a. In someembodiments, the connector 332 can extend directly from the supportmember 324, and in some embodiments, a portion of tubing can extendbetween the connector 332 and the fluid pathway through the supportmember 324. In FIG. 31, the connector 332 is shown extending away fromthe front side 328 of the attachment 304 for illustration purposes. Insome embodiments, the support member 324 can be attached to theattachment 304 backwards from the orientation shown in FIG. 31, so thatthe connector 332 extends away from back side 330 of the attachment 304and towards the transfer station 218 (as shown in FIG. 30).

The support member 324 can have a spike 334 extending from the flange326 towards the IV bag 224. A fluid pathway can extend from theconnector 332, through the support member 324, out the spike 334, andinto the IV bag 224. In some embodiments, a tube 336 can extend from thesupport member 324 to allow a supplemental fluid to be transferred intothe IV bag 224 in addition to the fluid transferred by the transferstation 218. For example, in some embodiments, the fluid transferstation 218 can transfer a medication into the IV bag 224, and anadditional transfer station (e.g., 218 b of FIG. 2) can transfer salineor other diluent into the IV bag 224 to obtain a specified concentrationof the medication. Thus, in some embodiments, two input fluid pathwayscan combine (e.g., by a T- or Y-Connection) into a single output fluidpathway leading to the IV bag 224. In some embodiments, one or morecheck valves can be included to prevent fluid from the first fluid inputfrom being driven out of the second fluid input and/or to prevent fluidfrom the second fluid input from being driven out of the first fluidinput. In some embodiments, the fluid tube 336 can be omitted (e.g., ifonly one fluid is to be transferred to the IV bag 224), or the fluidtube 336 can be attached to the IV bag 224 by a supplemental line 225 ofthe IV bag 224.

The extension 312 that connects the first side 306 to the second side308 of the attachment 304 can be located at a back portion of the gap310 (e.g., the lower back portion) nearer to the transfer station 218.Thus, the support member 324 can be inserted into the gap 310 (e.g.,with the flange 326 engaging the grooves 322 a-b) from the front side328 of the attachment 304 without disconnecting the attachment 304 fromthe transfer station 218. This can facilitate replacement of the IV bag224. As shown in FIG. 29, the bottom of the gap 310 can be generallyopen to allow a fluid line to lead to the IV bag 224 and/or the top ofthe gap 310 can be generally open to receive the tube 336. In someembodiments the gap 310 can create an open pathway 338 leadingsubstantially vertically through the attachment 304. The front of thegap 310 can be generally open (or completely open) to allow the supportmember 324 to be inserted therethrough. The back of the gap 310 can begenerally open to receive the connector 332. In some embodiments, thegap can define an open pathway 340 extending substantially horizontallythrough the attachment 304. In some embodiments, the open substantiallyhorizontal pathway 340 can allow a fluid line to extend through theattachment 304. For example, the attachment 304 can be attached to ashaft 302 that supports a tray 300 (as shown in FIG. 28), so that userhas the option to position the IV bag 224 in the generally verticalconfiguration by attaching the IV bag 224 to the attachment 304 (e.g.,using the support member 324), or to position the IV bag 224 in thegenerally horizontal configuration by laying the IV bag 224 on the tray300. When the IV bag 224 is on the tray 300, the fluid line extendingbetween the IV bag 224 and the connector 226 can pass through the gap310 of the attachment 304, (e.g., generally along the substantiallyhorizontal pathway 340).

Many variations are possible. For example, the back side of the gap 310can be closed, and the connector 332 can be positioned higher on thesupport member 324 than illustrated so that the connector 332 so thatthe connector 332 can clear the attachment 304 as the support member 324is inserted through the front of the gap 310.

FIG. 32 shows the fluid transfer system 200 using a fluid bag 342instead of the source fluid vial 220 b shown in FIG. 2. In someembodiments, a drip chamber 344 can be positioned between a source fluidcontainer (e.g., the fluid bag 342, or vial 220 a, or vial 220 b) andthe corresponding syringe pump to prevent air bubbles from being drawntowards the syringe pump, until the source fluid container runs dry. Insome embodiments, an air detector 346 can be positioned between thefluid source (e.g., fluid bag 342) and the syringe pump. In someembodiments, the air detector 346 can be clamped, or otherwise attached,to the fluid line below the drip chamber 344. The air detector 346 caninclude a light source and light sensor similar to the other airdetectors discussed herein. The air detector 346 can be in configured toprovide a signal to a controller when air is detected, indicating thatthe fluid source may need to be replaced.

As shown in FIG. 32, the system 200 can include a foot pedal 348 incommunication with a controller for the system 200. The foot pedal 348can be configured to provide user input to the system 200, which can beused in addition to or instead of input received through the userinterface 208. In some embodiments, the foot pedal 348 can issue arepeat command that causes the system 200 to perform a fluid transfer ofthe same amount as the previous fluid transfer. The foot pedal 348 canallow the user to have both hands free (e.g., to replace IV bags aftereach fluid transfer of a multiple-IV bag order). The foot pedal 348 canprovide various other signals to the controller, such as an acceptcommand, a pause command, a start command, a cancel command, etc.

The system 200 can be in communication with an external system 343 by acable or wire attached to a port on the fluid transfer system 200, or bya wireless communication connection, or any other suitable dataconnection. The external system 343 can be an external controller, aterminal (such as a computer), or an automated management system (suchas a hospital information system (HIS)), etc. In some embodiments, thesystem can receive instructions from the external system 343. Forexample, in some cases the system 200 does not include a user interfaceas part of the system 200, and the controller can be configured toreceive instructions from the external system 343, which can be acomputer running a software program configured to provide instructionsfor the system 200. For example, the external computer 343 can provide auser interface to the user and can receive input from a user and cangenerate instructions for the system 200 based on the user input. Insome embodiments, the external system 343 can be configured to interfacea hospital information system (HIS) to generate instructions for thesystem 200, which can be, for example, based on requests or informationgathered from a large number of terminals. In some embodiments, asoftware program running on the external computer 343 can coordinatefluid transfer tasks between two or more fluid transfer systems. Thesoftware program can also be used to calculate sophisticatedconfigurations of dosages, to track dosage amounts for individualpatients, and to provide warnings if problems are identified withpatient dosage requests or other data.

In some embodiments, the external system 343 can include a printer thatcan be configured to automatically print labels for use with the fluidtransfer system 200. For example, when a fluid transfer is performed,the printer can print a label automatically to be placed on the targetcontainer (e.g., IV bag). The label can include information such as thefluid type, the concentration, the amount of fluid, the intendedpatient, the requesting doctor, etc. In some embodiments, the printercan be directly attached to the fluid transfer system 200, such as by awire or cable extending from a port on the system 200 or by a wirelessdata connection. The controller of the system 200 can be configured togenerate the printer instructions for printing the labels. Though shownas an external system 343 with various possible applications, in someembodiments, some or all of the aspects of the external system 343 maybe incorporated into the fluid transfer system 200.

In some embodiments, the system 200 can be used in combination with afume hood 350. For example, a fume hood 350 is shown schematically inFIG. 33 with a fluid transfer system 200 inside of a ventilation area352. An exhaust duct 354 can remove air from the ventilation area 352,which can prevent or reduce the occurrence of any leaked fluids or othermaterials escaping from the ventilation area 352. The fume hood 350 canalso include one or more baffles 356 to control the flow of air throughthe ventilation area 352.

FIG. 34 is a flowchart showing a method 360 for transferring fluid usinga fluid transfer system and a fume hood. At block 362, a fluid transfersystem can be positioned in a flume hood, as shown in FIG. 33, forexample. In some embodiments, block 362 can be omitted, for example, ifthe fluid transfer system is already located in the fume hood. At block364, the fume hood can be activated, thereby producing a flow of airthat can prevent or reduce the amount of particles escaping from thefume hood. At block 366, the fluid transfer system can be used totransfer fluid, or some other operation can be performed using the fluidtransfer system. In some embodiments, the fume hood can be activated forsome actions and deactivated for other actions. For example, the fumehood can be activated when connectors on the fluid transfer system arebeing disengaged and/or engaged (e.g., when replacing an IV bag or fluidvial). In some embodiments, the fume hood can be turned off during fluidtransfer. In some embodiments, the system can be in operablecommunication with the fume hood so that the system can automaticallyactivate and deactivate the fume hood as needed. For example, when thesystem receives a fluid transfer instruction, the system can activatethe fume hood, and the system can deactivate the fume hood aftercompletion of the fluid transfer.

FIG. 35 is a detailed view of the connector 226 b for the second fluidtransfer station 218 b of the system 200 (also shown in FIG. 2). Theconnector 226 b can have an inlet 370 configured to receive the tube 230for transferring fluid from a source container (e.g., a saline vial orbag) to the connector 226 b, and an outlet 372 configured to receivetube 236 for transferring fluid from the connector 226 b towards atarget container. A syringe 222 b can be attached to an intermediateconnection 374 of the connector 226 b. The connector 226 b can have oneor more check valves configured to control the flow of fluid through theconnector 226 b. When the syringe plunger is retracted, fluid can flowfrom the tube 230, into the inlet 370, to the intermediate connection374, and into the syringe 222 b, and the one or more check valves canprevent fluid from flowing into the connector 226 b from the outlet 372.When the syringe plunger is advanced, fluid can flow from the syringe222 b, into the intermediate connection 374, through the connector 226b, and out the outlet 372 and tube 236, and the one or more check valvescan prevent fluid from flowing out of the connector 226 b through theinlet 370. The one or more check valves can include a duckbillstructure, a disc, a flap, or any other suitable check valve structure.

Thus, in some regards, the transfer station 218 b and connector 226 bcan operate in a manner similar to the transfer station 218 a and 226 adescribed herein. In some embodiments, the transfer station 218 b can beconfigured for transfer of fluids that are not dangerous, expensive, orsensitive to ambient air (e.g., saline or water). For example, in someembodiments, the transfer station 218 b does not include correspondingconnectors (e.g., male and female closable luer connectors) configuredto prevent leaking of fluids during changing of components. In someembodiments, the fluid transfer system 200 can be used to transfer onlyfluids that are not dangerous, expensive, or sensitive to ambient air(e.g., saline or water), for example, for reconstitution or dilution ofmedications. FIG. 36 is a perspective view of a fluid transfer system400, which can be similar to, or the same as, the fluid transfer system200 in many regards, except that the fluid transfer system 400 does notinclude a fluid transfer station configured to transfer fluids withoutexposure to the ambient environment. For example, the system 400 caninclude a single transfer station 418 that can be similar to, or thesame as, the transfer station 218 b of the system 200. In someembodiments, the housing 402 can be smaller than in the illustratedembodiment.

In some embodiments, the system 200 and the system 400 can be used as areconstituting or diluting device by transferring a reconstituting fluidor diluent into a target container 424 (e.g., a vial). Although somedisclosure relating to reconstitution and/or dilution is discussed inrelation to the transfer station 418 of system 400, the transfer station218 b of system 200 can also be used. Although the transfer station 218a can also be used for reconstitution and/or dilution, in someembodiments, the transfer stations 218 b and 418 can provide a simplersolution than 218 a.

In some embodiments, a vial adapter 500 can be used to provide access tothe internal chamber of the vial 424. The vial adapter can be apressure-regulated vial adapter, such as a version of the Genie® vialadapter, manufactured by ICU Medical, Inc., of San Clemente, Calif.).Various embodiments and features relating to the vial adapter 500 aredisclosed in the '157 Publication.

One embodiment of a vial adapter 500 is illustrated in FIGS. 37-40. Thevial adapter 500 can include a piercing member 520, including a tip 524and a plurality of sleeve members 503, which can be biased outwardly.The sleeve member 503 can meet at a base 504 of piercing member 520. Insome embodiments, the sleeve members 503 can be held closed prior toinsertion of the piercing member 520 through a septum of the vial 424(e.g., using a jacket 505), as shown in FIG. 37. As the piercing member520 is inserted through the septum, the jacket 505 can be slide down thepiercing member 520 by the septum until the sleeves 503 are allowed toopen (as shown in FIG. 38). When the sleeves 503 open, a bag 560 can bedeployed and can be partially filed with air that enters the vialadapter 500 via an air hole 508. Thus, in the default resting position,the bag 560 can occupy a first volume within the vial 424.

The vial 424 can include a concentrated medication, which can be inpowder form, and fluid (e.g., saline or water) can be transferred intothe vial 424 using the fluid transfer station 418 of the system 400 todilute or reconstitute the medication. Fluid can enter and/or exit thevial 424 via the fluid pathway 510. Fluid can be transferred byretracting the plunger of the syringe by a specified amountcorresponding to the desired volume of fluid from a source container(e.g., vial 420), and by advancing the plunger to drive the fluid fromthe syringe 422 into the vial 424. As the fluid enters the vial 424, thebag 560 can deflate, as shown in FIG. 39 to a second volume that issmaller than the first volume, and air from the bag 560 can be expelledvia the air hole 508. Thus, the bag 560 can change in volume to prevent,or reduce, pressure from building up inside the vial 424.

Once reconstituted or diluted, fluid from the vial 424 can be withdrawn(e.g., for administration to a patient or other use). The vial 424 andvial adapter 500 can be disconnected from the fluid transfer system, forexample, by disengaging the connector 440 (which can be coupled to thevial adapter 500) from the connector 438 (which can be coupled to thetube 436). The vial adapter 500 can remain attached to the vial 424, andthe bag 560 an remain in the at least partially deflated state whiledisengaged. The connector 440 attached to the vial adapter 500 can beconfigured to close when disengaged to prevent fluid from the vial 424from escaping. Fluid can be withdrawn from the vial 424 by engaging theconnector 440 with a corresponding connector to reestablish a fluidconnection to the internal chamber of the vial 424. For example, thevial 424 and vial adapter 500 can be attached to a transfer station(e.g., 218 a or 218 b), for example, in order to transfer preciseamounts of the reconstituted and/or diluted fluid from the vial 424 to atarget container (e.g., an IV bag). As fluid is withdrawn from the vial424, the bag 560 can inflate to a third volume that is larger than thesecond volume to at least partially compensate for the volume of fluidremoved from the vial 424. The third volume can be smaller than thefirst volume, for example, if only a small portion of the fluid iswithdrawn, or the third volume can be larger than the first volume, forexample, if a relatively large volume of fluid is withdrawn from thevial 424.

Many vial adapter designs can be used other than that shown in theillustrated embodiments. Additional embodiments and details are providedin the '157 Publication.

FIG. 41 is a perspective view of an example embodiment of a portion of atransfer station 618, which can have features similar to, or the sameas, other transfer stations disclosed herein. FIG. 41 illustrates anupper mounting portion 654 having a base member 660 and a cassette 662.A connector 626 can be received by the upper mounting portion 654 in amanner similar to that described herein for the connector 226 a andupper mounting portion 254. The connector 626 can include a sourceconnector portion 664 and a target connector portion 668, one or both ofwhich can be similar to, or the same as the closable male connector 1100in the '793 application. FIG. 42 shows the male connector 1100 with acorresponding female connector 1400 (also described in the '793application) in a disengaged configuration. It will be understood thatvarious connectors described herein can be replaced with the connectors1100 and 1400 from the '793 application. The '793 application alsodiscloses a male connector 100 and a female connector 400, which can beused in place of various connectors disclosed herein. Also, where a maleconnector is described, in some cases a female connector can be used,and vise versa. Thus, the connector 626 can use female connectors 1400for the source connector portion 664 and/or for the target connectorportion 668. The '793 application also discloses a male connector,identified by reference number 100, and a corresponding femaleconnector, identified by reference number 400, that can be used in placeof various connectors described herein.

Various types of target containers can be used. For example, as shown inFIG. 43, the fluid transfer system 200 can be used to transfer fluidinto an elastomeric pump 390. In some embodiments, an elastomeric pump390 can include a bladder that can be filled with a fluid causing thebladder to stretch and exert a pressure on the fluid therein. The outletof the elastomeric pump can restrict the flow of fluid so that thepressure drives the fluid out of the bladder via the outlet at agenerally constant rate over a time (e.g., one hour to several days). Insome embodiments, a considerable force may be required to fill theelastomeric pump 390 since filling is resisted by the expanding bladder.The resistance can make it difficult to fill the elastomeric pump 390 byhand, especially if done repeatedly, and especially if precise amountsof fluid are to be transferred. Thus, using the system 200 to fillelastomeric pumps 390 can increase speed and accuracy and can decreasefatigue on an operator.

FIG. 44 is a flow diagram of a method 700 for filing an elastomeric pump390. At block 702, the elastomeric pump 390 is attached to the system200. For example, a tube leading to the elastomeric pump 390 can have afemale connector that is configured to interface with a male connectorportion on the outlet of the connector 226. At block 704, a specifiedfluid can be provided by attaching a vial 220 to the system 200. In someembodiments, block 704 can be omitted if the specified fluid is alreadyin the attached vial 220. At block 706, the system 200 can transferfluid into the elastomeric pump 390 by actuation the syringe plunger asdescribed herein. The motor of the system 200 can be configured toovercome the resistance provided by the expanding bladder of theelastomeric pump 390 and can be configured to stop once the desiredamount of fluid has been transferred.

In some embodiments, the fluid transfer system can be configured toclear fluid out of the fluidics system, either automatically or uponinstructions received from an operator (e.g., using a “clear” button).FIG. 45 is a flowchart showing an example method 750 of a fluid clearingmethod. At block 752, the system can transfer fluid. For example, thesystem can actuate a plunger of a syringe pump to draw fluid out of asource container (e.g., vial) and the system can advance the plunger todrive the fluid from the syringe pump into a target container (e.g., IVbag), as described herein. Once the specified amount of fluid has beentransferred, the target container can be removed at block 754. In someembodiments, another target container can be attached to the system andanother fluid transfer procedure can be performed using the same type offluid drawn from the same source container. However, in someembodiments, the source container can be removed at block 756, forexample, if no additional fluid transfers are to be performed and thesystem is to be shut down, or if a next fluid transfer is for adifferent type of fluid. In some embodiments, a volume of fluid remainsin the connector after a fluid transfer, and the system can be used toflush the remaining fluid out of the connector so that the flushed fluid(which can be expensive) can be recovered for later use.

At block 758, a new target container can be attached to receive theflushed fluid. For example, the vial (or other container) that was usedas the source container for the fluid can be attached to the system asthe target container so that the flushed fluid can be directed back intothe container were it started. In some embodiments, the vial orassociated vial adapter can be configured to regulate pressure in thevial as the flushed fluid is inserted therein, for example, by deflatinga volume variable bag associated therewith, as described in the '157Publication. In some embodiments, the vial and/or vial adapter does nothave a variable volume component and the volume inserted into the vialcan be small enough that the pressure in the vial is not raised beyondan acceptable threshold.

At block 760, a new source attachment can be attached to the system. Thesource attachment can allow air to be drawn into the connector. Forexample, the new source attachment can be an empty vial and adaptersimilar to the vial 3907 and adapter 3908 of FIGS. 7 and 8. Air canenter through the filter 3948 and pass through the empty vial 3907, passthrough the female connector 3944, and enter the connector to flush thefluid contained therein. In some embodiments, the source attachment doesnot include a vial or other container. For example, FIG. 46 shows anexample embodiment of an air source attachment 770 that includes aconnector 772 that is configured to engage the source connector portionof the connector being flushed. An air intake element 774 can beattached to the connector 772. The air intake element 774 can include aone way air valve or filter 776 configured to allow air to enter the airintake element 774 and to prevent air from exiting through the filter776. A pathway can lead from the filter 776 to the connector 772 toallow air to enter through the filter 776 and travel through theconnector 772. In some embodiments, the air intake element can beintegrally formed with the connector, for example, by placing the filter776 at the male end of the connector 772 shown.

In some embodiments, a fluid source container can be attached at block760, for example, to flush the fluid out of the connector using salineor water. However, in some embodiments, the fluid being flushed canbecome diluted or contaminated by the flushing fluid. Thus, it can beadvantageous to use air in some embodiments. In some embodiments aflushing fluid can be used, such as a cleaning liquid, to flush theconnector in order to clean the connector. In some embodiments, theconnector can be cleaned for later use. In some embodiments, theconnector can be disposable, and can be cleaned with a flushing fluidprior to being discarded, for example, if the transferred fluid ishazardous.

At block 762, the system can flush fluid from the connector into thetarget container (e.g., into the vial that had been used as the sourcecontainer). For example, the syringe pump can draw air (or otherflushing fluid) through the inlet of the connector, and the syringe pumpcan then push the air out through the connector outlet towards thetarget container so that the air drives some or all the fluid out of theconnector and into the target container (e.g., the vial that had beenthe source container). In some embodiment, the system can flush theconnector at block 762 in response to input received from a user or froman outside system, such as by pressing a “clear cassette” or “flush”button. In some embodiments, the system can be configured to disregardthe air bubble sensor during the flushing procedure so that the systemdoes not stop the motor when air is detected entering the connector.

FIG. 47 is an example embodiment of a method 780 for flushing theconnector. At block 782 the system can receive a flush instruction. Theflush instruction can come from a user through a user interface (e.g.,by pressing a “clear cassette” or “flush” button, or from an outsidesystem via a data connection to the system). At block 784 the system canprompt the user (e.g., via the user interface) to attach, or confirmattachment of, the new source attachment (e.g., air source attachment770) to the connector. At block 786 the system can prompt the user(e.g., via the user interface) to attach, or confirm attachment of, anappropriate target container, which can be the container that had servedas the source container during the last fluid transfer.

At block 788, the system can actuate the syringe pump, which in somecases can be the first of multiple syringe actuations for flushing theconnector. Actuating the syringe can draw air (or flushing fluid)through the connector to drive some or all of the transferred fluid outof the connector. In some embodiments, the system can actuate thesyringe a second time at block 790, and can actuate the syringe anynumber of additional times as needed to drive residual fluid out of theconnector. The system can disregard the air bubble sensor so that air isallowed to be drawn through the connector during the flushing procedure.The method 780 can be modified, for example, to omit one or more ofblocks 784, 786, and 790. Thus, in some embodiments, the system caninitiate a flushing procedure after receiving a flush instructionwithout making prompts to a user, and in some embodiments, only a singlesyringe actuation is used.

Flushing of the connector will be further described in connection withFIG. 48, which is a cross sectional view of a connector 800, which canbe similar to, or the same as, other connectors disclosed herein. Theconnector 800 can have a fluid pathway portion A that includes the fluidpathway through the source connector portion 802 and into the connectorbody 804 up until the source check valve 806. A fluid pathway portion Bcan be the area between (e.g., below) the source check valve 806 and thetarget check valve 808, and extending into the syringe 810. The fluidpathway portion C can extend from the target check valve 808 out throughthe target connector portion 812.

During a first syringe actuation (block 788), the syringe plunger can bewithdrawn so that air can be drawn through the fluid pathway portions Aand B and into the syringe 810. The air can push the fluid from thepathway portion A down towards the syringe 810. Thus, once the syringeplunger is retracted, fluid pathway portions A and B can be filled withair and substantially no fluid. In some embodiments, Gravity can causethe fluid to move to the bottom of the syringe 810 with air positionedabove the fluid. When the plunger is driven forward, the air can bedriven up into the connector body 804 followed by the fluid. The airdriven up from the syringe 810 can pass through the target check valve808 and drive fluid in the fluid pathway portion C out through thetarget connector portion. Once the air is expelled from the syringe 810,the fluid that was below the air in the syringe 810 can be pushed upinto the connector body 804. Thus, when the plunger is fully advancedafter the first syringe actuation (block 788), the fluid pathway portionB can at least partially be filled with the fluid that had been in thesyringe 810 below the air. In some embodiments, the fluid pathwayportion B can be substantially filled with that fluid, and in some casethe fluid expelled from the syringe 810 can extend into the fluidpathway portion C. Fluid pathway portion A can have substantially nofluid therein at this stage.

At block 790, the syringe 810 can be actuated additional time(s).Additional air can be drawn through the fluid pathway portions A and Binto the syringe 810 as the plunger is retracted. The fluid in pathwayportion B can drop into the syringe 810 and can be positioned below theair. Fluid that had crossed the target check valve 808 into pathwayportion C can remain in pathway portion C as the plunger is retracted.Then, when the plunger is advanced, first the air and then the fluid canbe pushed from the syringe 810 into the connector body 804. The air canbe driven through the target check valve 808 and through the fluidpathway portion C, thereby pushing the fluid from fluid pathway portionC out of the connector 800 and into a target container. The fluid thathad been below the air in the syringe 810 can be pushed up into fluidpathway portion B. In some embodiments, after the second syringeactuation, the volume of fluid left in fluid pathway portion B can besmaller than the volume of fluid pathway portion B so that none orsubstantially none of the fluid crosses the target check valve 808 intofluid pathway portion C. Thus, in some embodiments, additional syringeactuations can merely cause the residual fluid in fluid pathway portionB to move to and from the syringe 810 without driving additional fluidout through fluid pathway portion C. In some embodiments, it may beacceptable for an amount of residual fluid to remain in the fluidpathway portion B after the flushing process.

In some embodiments, the connector 800, the syringe 810, and/or othercomponents can be reoriented to facilitate flushing of connector 800.For example, by placing the connector 800 and/or the syringe 810 upsidedown during the syringe actuation (block 788 or block 790), the fluidcan be driven out of the syringe 810 before the air. Thus, after theplunger is advanced, the fluid pathway portion B can be filled with airand substantially no fluid. Fluid pathway portions A and C can also befilled with air and substantially no fluid in this embodiment. Thus, insome embodiments, system can be configured to reorient the connector800, the syringe 810, and/or other components during some or all of thefluid flush process. In some embodiments, the system can have a rotationmechanism that allows or causes the connector 800 and/or the syringe 810to be rotated to an upside down configuration. The system can, in someembodiments, prompt the user to reorient the connector 800 and/or thesyringe 810. In some embodiments, the flushing can be performed by auser after disconnecting the connector 800 and/or the syringe 810 fromthe system.

In some embodiments, the connector 800 can be configured differentlythan as shown so that the syringe 810 is oriented to allow fluid to bedriven out of the syringe 810 before air. For example, the syringe 810can be oriented upside down from the orientation shown in FIG. 48 sothat the plunger is above the syringe outlet. In some embodiments, theconnector 800 can be similar to that shown in FIG. 48 but with theentire connector 800 oriented upside down from the orientation shown. Insome such embodiments, the source container can be connected to thesource connector portion 802 by a tube so that the source containerportion (e.g., vial) can be positioned with its outlet facing downward.In some embodiments, the connector 800 can be similar to that shown inFIG. 48 but the syringe 810 can be connected to the connector body 804by a length of tubing so that the syringe can be oriented with theplunger facing upward.

In some embodiments, the addition of tubing between the connector 800and the syringe 810 or the source container (e.g., vial) can introduceadditional volume to the fluidics of the system, which can beundesirable in some cases, for example leading to additional fluidwaste. Thus, as shown semi-schematically in FIG. 49, in someembodiments, the connector 900 can be configured to have both the sourceconnector portion 902 and the syringe 910 extending upwardly from theconnector body 904. Thus, when flushing the connector 900, in someembodiments, only a single syringe actuation is used to substantiallyclear the fluid pathway portions A, B, and C of fluid.

In some embodiments, the system can be configured to accommodate theSyringe being oriented upwardly, as shown in FIG. 49 for example. Forexample, in some embodiments, when transferring fluid, a pocket of aircan be maintained in the syringe (e.g., about equal to the volume offluid pathway portion B), and the system can adjust the fluid transfercalculations accordingly. Also, when performing an initial transfer offluid through a dry connector, the system can be configured to prime theconnector by actuating the syringe plunger by a predetermined amountthat is configured to position the leading edge of the fluid at aspecific location (e.g., at or near the entrance to the IV bag or IV bagassembly). If the syringe is oriented upwardly (as shown in FIG. 49),air that is drawn into the syringe can exit after the initial fluid thatis drawn into the syringe resulting in air being located behind theleading edge of the fluid. In some embodiments, the priming process canbe modified to accommodate for the air behind the initial portion offluid. For example, in some embodiments, the priming process can pushthe initial portion or fluid into the target container and drive theleading edge after the air up to the specified priming location. Thevolume of the initial portion of fluid can be calculated from the knownvolumes of the fluid pathway portions and by the amount that the syringewas actuated. The system can subtract the volume of the initial portionof fluid that was pushed into the target container from the initialfluid transfer volume.

In some embodiments, the system can omit the priming process and canmerely adjust the calculations for an initial fluid transfer toaccommodate for the air that will be pushed in to the target containerfrom the dry connector. For example, when the system receives a fluidtransfer command, if the system determines that the connector has notbeen primed, the system can initiate the fluid transfer process, but adda predetermined additional volume to the transfer to accommodate for theair that will be pushed into the target container. In some embodiments,the volume for one or both of the first two syringe actuations can beaffected. For example, the first syringe actuation can transfer theinitial portion of fluid towards or into the target container, and theinitial portion of fluid can be followed by air, as described above,when the syringe is oriented upwardly. Thus, in some embodiments, thesecond syringe actuation can drive the remaining air into the targetconnector along with fluid behind the air portion. In some embodiments,subsequent syringe actuations (e.g., after the first two actuations) cantransfer fluid into the target container without pushing substantiallyany air into the target container. In some embodiments, a pocket of aircan remain in the syringe (e.g., adjacent to the plunger surface), butis not transferred substantially beyond fluid pathway portion B. Thisair pocket can facilitate flushing of the connector once fluid transfersare complete by preventing fluid from remaining trapped in fluid pathwayportion B during flushing.

In some embodiments, the system can be configured to flush the fluidfrom the connector into a target container as the final volume of fluidfor a fluid transfer. Thus, in some embodiments, the user does not needto change the target container when flushing the connector. FIG. 50 is aflow chart showing an example embodiment of a method for flushing theconnector. At block 922, the system can receive a final fluid transferinstruction, which can be received from a user (e.g., via a userinterface) or by an outside system (e.g., via a data connection). Forexample, the user interface can have a button that allows the user tospecify that a particular fluid transfer will be the last performedbefore removing the source container and/or other components. The finaltransfer instruction can also include an indication of the volume offluid to be transferred.

At block 924, the system can calculate a fluid transfer sub-volume, forexample, by subtracting a known or calculated flush volume from thevolume to be transferred. At block 926, the system can transfer thesub-volume of fluid from the source container to the target container asdescribed herein, and the system can stop the fluid transfer once thesub-volume has been transferred. At block 928, the system can access anair source. For example, the system can prompt the user to remove thesource container (e.g., vial) and attach an air source attachment (e.g.,attachment 770). At block 930, the system can flush the fluid out of theconnector as described herein to drive the flushed fluid into the targetcontainer (e.g., IV bag). In some embodiments, some air can be driveninto the target container along with the fluid. The volume of the fluidflushed into the target container can be predetermined or calculatedbased on the known volumes of the portions of the fluid pathway throughthe fluidics system. The fluid transfer sub-volume, which is driven intothe target container prior to the flush process, and the flushed fluidvolume can add to substantially equal the specified volume of fluid tobe transferred in the received instructions.

In some embodiments, saline or water or other liquid can be used toflush the connector. Thus, the embodiments described herein can bemodified to use a flushing liquid instead of air. For example, in themethod 750 of FIG. 45, the user can remove the source container at block756 and attach a fluid connection to a flushing fluid at block 760. Forexample a saline bag can used, and an outlet tube from the saline bagcan have a connector at the end that is configured to engage the sourceconnector portion (e.g., 802 in FIG. 48). Although several embodimentsdiscuss flushing with saline, other fluids can be used (e.g., water or acleaning solution). In the method 780 of FIG. 47, the system can promptthe user to attach a saline (or other fluid) source at block 784. InFIG. 50, the method 920 can access a flushing fluid source at block 928,which can include prompting a user to attach a flushing fluid source tothe source connector portion.

In some embodiments, the flushing fluid can be used to dilute thetransferred fluid. For example in some embodiments, the method 920 ofFIG. 50 can be modified as mentioned to provide access to a diluentfluid (e.g., saline) at block 928. The system can transfer a specifiedor calculated amount of saline through the connector to attain thespecified concentration for the transferred fluid. Thus, the finalportion of the concentrated fluid can be flushed through the connectorby the diluent fluid and the diluent fluid transfer can continue untilthe desired concentration is reached.

FIG. 51 is a flowchart showing a method 950 for transferring a dilutingfluid for diluting a concentrated fluid to a specified concentration. Atblock 952, the system can receive a final fluid transfer instruction ina manner similar to that described for block 922. The instructions caninclude a specified volume for the concentrated fluid and a specifiedvolume for the diluent to be transferred, or the instructions caninclude a specified concentration and amount for the final mixture andthe volumes for the concentrated fluid and diluent can be calculated bythe system. At block 954 the system can calculate a sub-volume for theconcentrated fluid, for example by subtracting a volume for the amountof the concentrated fluid expected to be flushed from the connectorduring a flush procedure from the total volume of the concentrated fluidto be transferred. At block 956, the system can transfer the sub-volumeof the concentrated fluid from the source container to the targetcontainer as described herein.

At block 958, the system can calculate a diluting fluid sub-volume, forexample, by subtracting a diluting fluid flush volume from the totaldiluting fluid volume to be transferred. At block 960, the system cantransfer the diluting fluid sub-volume from a diluting fluid sourcecontainer to the target container. In some embodiments, the transfer ofthe concentrated fluid sub-volume, at block 956, can be performed by afirst fluid transfer station and the transfer of the diluting fluidsub-volume, at block 960, can be performed by a second fluid transferstation. In some cases, the transfer of the concentrated fluidsub-volume, at block 956, can be performed simultaneously with thetransfer of the diluting fluid sub-volume, at block 960.

At block 962, the system can access the diluting fluid through theconnector used to transfer the concentrated fluid. For example, thesystem can prompt the user to change the connections so that thediluting fluid source (e.g., saline bag) is attached to the sourceconnector portion of the connector that had been used to transfer theconcentrated fluid. At block 964, the system can flush the remainingconcentrated fluid out of the connector using the diluting fluid. Theamount of diluting fluid pushed through the connector can be configuredso that the diluting fluid flush volume used in the calculation of block958 is pushed into the target container along with the remainingconcentrated fluid. In some embodiments, more fluid than the dilutingfluid flush volume is actually drawn into the connector because dilutingfluid can be left in the connector after the flush is completed. Thusonce the flush is completed, the concentrated fluid sub-volume and theconcentrated fluid flush volume can add to provide the amount ofconcentrated fluid needed to attain the desired amount and concentrationfor the mixture. Similarly, once the flush is completed, the dilutingfluid sub-volume and the diluting fluid flush volume can add to providethe amount of diluting fluid needed to attain the desired amount andconcentration for the mixture.

In some embodiments, the system can be configured to automaticallyaccess air or a flushing fluid for flushing the connector. For example,a source switching system 980 is shown schematically in FIG. 52. Thesystem 980 can include a source fluid container 982 (e.g., a vial) and aflushing source 984. The flushing source 984 be a source of a flushingfluid (e.g., saline, water, or a cleaning solution), or the flushingsource 984 can provide access to air for flushing a connector. Forexample, an air inlet can be provided by a one way valve or filter. Afluid switch 986 can provide fluid communication to the source fluidcontainer 982 or the flushing source 984. The fluid switch 986 can be astopcock or other switch that can be actuated between at least twoconfigurations. A first configuration can open a fluid pathway betweenthe source fluid container 982 and the connector 988 while closing thefluid pathway between the flushing source 984 and the connector. Thesecond configuration can open an fluid pathway between the flushingsource 984 and the connector 988 while closing the fluid pathway betweenthe source fluid container and the connector 988. The system can includean actuator 990 configured to toggle the actuator 986 between the firstand second configurations based on input received from the controller ofthe system.

The embodiments discussed herein relating to flushing the connector canbe modified to use the source switching system 980 or otherconfiguration that allows the system to automatically access air or aflushing fluid for flushing the connector. For example, in the method750 of FIG. 45, the system can actuate a fluid switch at block 760 toprovide access to air or to a flushing fluid. In some embodiments, block756 can be omitted so that the user does not remove the fluid sourcecontainer (e.g., vial).

For the method 780 of FIG. 47, the system can actuate a fluid switchbefore actuating the syringe pump at block 788, thereby providing accessto air or to a flushing fluid. In some embodiments, the block 784 can beomitted so that the system does not prompt the user regarding an airsource attachment. As discussed above, in some embodiments, block 786can also be omitted so that the system does not prompt the userregarding the target container, for example if the same target containeris to be used during the fluid transfer and the flush. Also as mentionedabove, in some embodiments, block 790 can be omitted so that the flushis performed in a single syringe actuation.

For the method 920 of FIG. 50, the system can actuate a fluid switch atblock 928 to provide access to air or to a flushing fluid. For themethod 950 of FIG. 51, the system can actuate a fluid switch at block962 so that the connector being flushed is in communication with thediluting fluid source.

FIGS. 53 and 54 illustrate an embodiment of a reservoir container 1000that can be used with the fluid delivery systems discussed herein. Thereservoir container 1000 comprises a reservoir body 1010, an upper endcap member 1020, and a lower end cap member 1030. The reservoir body hasan upper opening 1014 and a lower opening 1016. The reservoir body 1010has a substantially cylindrical shape that forms a cavity 1012. In theillustrated embodiment, the reservoir body 1010 generally decreases indiameter, or cross-sectional area, from the upper opening 1014 down tothe lower opening 1016. At the upper opening 1014, a portion of the bodyhas a generally constant diameter, or cross-sectional area, that issized and configured to couple with the upper end cap member 1020. Atthe lower opening 1016, a portion of the body has a generally constantdiameter, or cross-sectional area, that is sized and configured tocouple with the lower end cap member 1030. The interior wall of thereservoir body 1010 can have a plurality of struts or supports. Thesupports 1018 provide additional structural integrity to the reservoirbody 1010. The reservoir body 1010 is formed from a flexible material,such as a silicone rubber or a flexible polymeric material. Thereservoir body 1010 can be compressed laterally, causing the volume ofthe internal cavity to decrease. The reservoir body 1010 can formed froma material that can be elastically deformed and still generally maintainthe original shape of the body 1010 after rebounding from thedeformation. The reservoir body can be formed from a substantiallytransparent material.

The upper end cap member 1020 comprises a upper end cap wall 1024 and ahole 1022. The wall 1024 angles downward and a tube 1026 extendsdownwards into the cavity 1012 of the reservoir body 1010. The hole 1020is substantially positioned about a center axis of the upper end capmember 1020, which is substantially concentric with a center axis of thereservoir body. The length of the tube is sized and configured to engagea fluid connector (e.g., a Spiros® closeable male connector manufacturedby ICU Medical, Inc., of San Clemente, Calif.). The wall 1024 forms anupper mounting recess 1025. The mounting recess 1025 is sized andconfigured to engage the upper opening 1014 of the reservoir body 1010.The upper end cap member 1020 can be constructed from a rigid materialsuch as polycarbonate or other polymeric materials.

The lower end cap member 1030 comprises a lower end cap wall 1034 and ahole 1032. The wall 1024 forms an lower mounting recess 1035. Themounting recess 1035 is sized and configured to engage the lower opening1016 of the reservoir body 1010. The hole can be configured to engage afluid connector, such as a closeable male connector, or otherappropriate fixture. The lower end cap member 1030 can be constructedfrom a rigid material such as polycarbonate or other polymericmaterials.

The reservoir body 1010 is configured to have a fluid tight seal withthe upper end cap member 1020 and the lower end cap member 1030. Theopenings 1014, 1016 of the reservoir body can be permanently coupledwithin the upper mounting recess 1025 and the lower mounting recess1035. An adhesive or other suitable manner to form a fluid tightconnection between the reservoir body and the end cap members 1020,1030.

The reservoir body can have many different shapes, such as generallyspherical, generally conical, generally rectangular, generally cubical,etc. For example, the outer diameter of the reservoir body 1010 can begreater than the outer diameter of the end cap member.

FIGS. 54 and 55 illustrate an embodiment of the reservoir containercoupled to a fluidics assembly 3906′. FIG. 55 is a perspective view of afluidics assembly 3906′ that can be used with the first fluid transferstation 218 a. FIG. 56 is a perspective exploded view of the fluidicsassembly 3906 from a different angle than that shown in FIG. 55. Thefluid assembly 3906′ can be used to transfer precise amounts of fluidfrom a vial 3907 to an IV bag 3914. The fluidics assembly 3906′ includesa vial 3907, a vial adapter 3908 configured to provide fluidcommunication with the fluid (e.g., chemotherapy drug or othermedication) contained within the vial 3907, a reservoir container 1000,a syringe 3912, an IV bag assembly 3914, and a connector 3910 fordirecting fluid from the reservoir container 1000 into the syringe 3912and from the syringe 3912 toward the IV bag assembly 3914. The reservoircontainer 1000 can be used to transfer fluid from the vial 3907 via thevial adapter 3908 to the reservoir container 1000. A connector 3964 canbe fixedly coupled to the upper end cap member 1020 of the reservoircontainer 1000. The lower end cap member 1030 can be fixedly coupled tothe connector 3910. In some embodiments, the fluidics assembly 3906′ canhave features similar to, or the same as, those of the other fluidicssystems disclosed herein. For example, the connector 3910 can be thesame or substantially similar to the connector 226 a, also discussedherein.

FIGS. 57 and 58 illustrate an example of usage of the reservoircontainer 1000 in the fluidics assembly 3906′. FIG. 57 there is fluidcontained within the vial 3907. To transfer fluid from the vial to thereservoir container 1000, the reservoir container 1000 is compressed asshown. When the reservoir container 1000 is compressed, the volume ofthe internal cavity 1012 is decreased, thereby forcing air out of theinternal cavity and into the vial. When the reservoir container isreleased as shown in FIG. 58, a vacuum is created causing fluid to bedrawn from the vial 3907 to the cavity of the reservoir container 1000.In some embodiments, the vial adapter 3908 can be configured to allowair to enter the vial 3907 via the vial adapter 3908, therebysubstantially equalizing pressure in the vial 3907 as fluid is drawnout. The process of compressing and releasing the reservoir container1000 can be repeated until substantially all of the fluid from the vial3907 has been transferred to the reservoir container 1000. The fluidicsassembly 3906′ can be configured to allow the vial 3907 and vial adapter3908 to be replaced when the vial runs out of fluid without requiringthe replacement of the reservoir container 1000, connector 3910, orsyringe 3912. The vial can be replaced with another vial. The fluidcontents of the new vial can be transferred to the reservoir container1000 by compressing and releasing the reservoir container 1000. Thereservoir container 1000 can be sized such that it can hold the contentsof more than one vial.

FIG. 59 illustrates a method for transferring fluid from reservoircontainer to a target container with a fluid delivery system 1050, suchas the system 200. The fluid delivery system can have a fluidicsassembly with features similar to, or the same as, those of the otherfluidics systems disclosed herein. At block 1052, a source container(e.g., a medical vial or other suitable container such as a bag, abottle, or a vat, etc.) containing a fluid (e.g., chemotherapy drug orother medical fluid) is coupled to the fluid transfer system. The sourcecontainer is configured to be in fluid communication with the reservoircontainer 1000.

At block 1054, fluid is transferred from the source container to thereservoir container 1000. In some embodiments, the fluid is transferredby compressing and releasing the reservoir container. The process oftransferring the fluid to the reservoir container 1000 is repeated untilthe source container runs out of fluid. When the reservoir container1000 is compressed, the volume of the internal cavity 1012 is decreased,thereby forcing air out of the internal cavity and into the sourcecontainer. When the reservoir container is released, a vacuum is createdthereby drawing fluid out of the source container and into reservoircontainer 1000. The process of compressing and releasing the reservoircontainer can be performed by a lab technician. In some embodiments, theprocess can be performed by an automated mechanical system.

At block 1056 the source container is removed from the fluid transfersystem. In some embodiments, the fluidics system can be used to transferfluid while retaining substantially entirely, or entirely, all of thefluid within the system, permitting the fluid transfer to occur in asubstantially entirely, or entirely, closed system. The fluid deliverysystem can thereby reduce or eliminate the risk of injury, waste, ordamage caused by liquid or vapor leakage when connecting anddisconnecting the components of the fluidics system.

At block 1058 the process of transferring fluid as described in blocks1052 and 1054 can be repeated to transfer additional fluid to thereservoir container 1000. The reservoir container 1000 can be configuredto hold the contents of one or more source containers. The process canbe repeated until the desired amount of fluid has been transferred tothe reservoir container 1000 from the source containers. In someembodiments the reservoir container can be configured to hold at leastthe amount of fluid that will be transferred to a target container(e.g., an IV bag, an elastomeric pump, a syringe, or other suitablecontainer) in a typical dosage range used for patient treatment of aparticular type of medicinal fluid.

At block 1060 the fluid is transferred from the reservoir container 1000to the target container. The fluid can be transferred from the reservoircontainer to the source container using the fluid delivery system andprocedures for transferring fluid from the source container to thetarget as discussed herein.

The process of transferring the fluid from the one or more sourcecontainers to the reservoir container prior to transferring the fluid tothe target container can reduce the time that is required to fill thetarget container. For example, the reservoir container can be of asufficient size so that it does not need to be refilled in order tocompletely fill the target container. Additionally, in some embodiments,some or all of the steps associated with changing source containers canbe performed at the same time and a lab technician is not required toattend to the fluid delivery system as it is filling the targetcontainer. Additionally, the reservoir container can reduce thelikelihood that an air bubble is drawn into the fluidics system duringoperation because the source containers are not changed, or are changedless frequently during the transfer of fluid from the source containerto the target container.

FIG. 60 schematically shows an embodiment of an automated fluid transfersystem 1200. The system 1200 comprises one or more fluid transferstations 1218 a-b, a destination sensor, such as an end volume sensor ora weight sensor 1222, and a controller 1204. Although in the embodimentshown, the components are all contained within the housing 1202, avariety of other configurations are possible. For example, the system1200 can include one or more housings 1202 enclosing components of thevarious systems. In some embodiments, each component grouping can have aseparate housing (as illustrated by the dashed lines within the housing1202). In some embodiments the controller 1204 can be contained withinthe same housing as the first fluid transfer station 1218 a. In someembodiments there is a single fluid transfer station 1218 a. In someembodiments there can be a plurality (e.g., a first and a second) fluidtransfer stations 1218 a-b. In some embodiments the destination sensor1222 can be in a different housing than the fluid transfer stations 1218a-b and the controller 1204. In some embodiments, the controller 1204can be external to the housing 1202, and can be, for example containedwithin a second housing, which may also contain the user interface 1208.

The system 1200 has a controller 1204 and a memory module 1206. Thecontroller 1204 can be configured to control the operation and functionsof the fluid transfer stations 1218 a-b and the destination sensor 1222.The system 1200 can also include a user interface 1208, which can be,for example, external to the housing 1202. The user interface 1208 canalso be integrated into the housing 1202 in some cases. The userinterface 1208 can include, for example, a display, a keypad, and/or atouch screen display. The user interface 1208 can be configured toreceive instructions from the user, for example, regarding the amountsof fluid to be transferred and the types of fluids to be transferred.The user interface can also be configured to provide information to theuser, such as error messages, alerts, or instructions (e.g., to replacean empty vial). In some embodiments, the system 1200 can include acommunication interface 1210 configured to receive information (e.g.,instructions) from a remote source such as an external controller 1212,a terminal (such as a computer) 1214, or an automated management system(such as a hospital information system (HIS)) 1216, etc. In someembodiments, the communication interface can also send information(e.g., results or alerts) to the remote source. The communicationinterface can include one or more connection types and can be configuredto allow connectivity to multiple remote sources at once. In someembodiments, the system 1200 does not include a communication interface1205 and does not communicate with a remote source.

The destination sensor 1222 can include a communication interface 1221that can communicate with the controller 1204. In some embodiments aweight sensor 1222 can communicate with the controller using wirelesscommunication. In some embodiments a weight sensor 1222 can bephysically connected to the controller 1204 using a standardcommunication interface (e.g., RS232, USB, etc.). The controller 1204can receive information (e.g., measurements, current state of operation,etc.) and provide commands (e.g., zeroing the weight sensor) to theweight sensor 1220 through the communication interface 1221. In someembodiments the weight sensor 1222 can include a user interface 1223.The user interface can provide a visual indication of weight, and otherinformation. In some embodiments the weight sensor 1222 can receivecommands or instructions through the user interface 1223 from a user.

The destination sensor 1222 is used to determine the amount of fluidtransferred from the source container 1220 a-b to the target container1224. The destination sensor 1222 outputs the weight of the fluidtransferred to the target container to the controller 1204. Prior totransferring fluid, the scale can be programmatically zeroed in order tocompensate for the weight of the target container 1224. For example, abase weight can be assigned as “zero” fluid weight (i.e., equivalent tothe weight of the inherent scale weight and/or equivalent to theinherent scale weight plus a first fluid weight, and/or equivalent tothe weight of the target container). The scale can then determine therelative weight of the fluid transferred to the target container 1224beyond the base weight.

In some embodiments, the destination sensor 1222 is a scale that iscapable of receiving weight information and electronically providing theinformation to the controller 1204. The scale can be located in aseparate housing 1202. In some embodiments, the scale can have asubstantially flat weighing surface for the target container. In someembodiments (not illustrated) the scale can be a hanging scale.

In some embodiments, the fluid transfer station can include a positivedisplacement pump, such as a peristaltic pump, 1240 a-b, a motor 1242a-b and a fluidics assembly. The positive displacement pump 1240 a-b canbe used to pump fluid from a source container 1220 a-b to a targetcontainer 1224. The fluid is transferred via a hose 1228 a-b fittedinside a pump mounting interface 1244 a-b. A rotor with a number oflobes rotates and compresses the hose 1228 a-b progressively along anadvancing portion of the hose. As the lobe passes a particular portionof hose, such portion of hose rebounds to substantially its originalshape and internal volume. As the rotor turns, the part of hose 1228 a-bunder compression is pinched, thus, displacing fluid and forcing thefluid to move forward through the tube. The speed of the rotation of therotor, the number of lobes, and the material properties of the hoseinfluence the flow rate of the fluid through the system. The flow rateof the fluid transfer can be controlled by varying the speed of the pump1240 a-b. The motor 1242 a-b operating the pump 1240 a-b can run atvariable speeds. The peristaltic pump 1240 a-b can be configured tooperate at a low pressure. The pressure generated by the pump 1240 a-bcan be sufficiently low, such that it is below a threshold at which theconnector 1230 a-b will not leak if the pump is operating and theconnector 1230 a-b is not connected to the target container.

The operations of the pump can be controlled by the controller 1204. Insome embodiments, the housing 1202 incorporating the pump can have atouch screen that allows commands to be provided to the controller 1204.For example, a user can instruct the pump to transfer a specific amountof fluid to the target container. In some embodiments the commands canbe received from an external source such as a network computer. Thecontroller 1204 can operate the pump at variable speeds by controllingthe speed of the motor. The controller 1204 can control that rate atwhich the rotor is spinning, which, in turn, controls the fluid flowrate. In some embodiments, the computer can use an algorithm to reducethe speed of the motor as the amount of fluid approaches the desiredamount of fluid in the target container in order to increase accuracy.

Each fluid transfer station 1218 a-b can have a fluidics assembly thatincludes a first connector 1226 a-b, a hose 1228 a-b, and a secondconnector 1230 a-b. The hose 1228 a-b can be formed from a compressiblematerial (e.g., silicone rubber, and other elastomeric materials). Thehose 1228 a-b is configured to be inserted within the mounting interface1244 a-b of the peristaltic pump 1240 a-b (as illustrated by the dashedline) in order to facilitate the transfer of fluid between the sourcecontainer 1220 a-b and the target container 1224. Some embodiments canbe assembled from different types or portions of hose. In someembodiments, the hose 1228 a-b can be formed from a single material. Insome embodiments, the hose is formed with an elastomeric portion andother portions formed from polymeric materials. The first and secondconnectors 1226 a-b, 1230 a-b are fixedly coupled to the hose 1228 a-bat opposite ends and are not configured to be removable from the hose.The first connector 1226 a-b is configured to connect to the sourcecontainer 1220 a-b. In some embodiments, one or more pairs of male andfemale fluid connectors configured to be attached to each other toselectively permit the passage of fluid between the source container1220 a-b and the target container 1224. The connectors can be detachedor disconnected, for example, so that the target container 1224 can beremoved once the fluid has been transferred. In some embodiments, theconnectors can be configured to automatically close when disconnectedfrom a corresponding connector, thereby preventing fluid from escapingwhen the connectors are detached. Thus, the fluid transfer system 1200can be used to transfer fluid while retaining substantially entirely, orentirely, all of the fluid within the system, permitting the fluidtransfer to occur in a substantially entirely, or entirely, closedsystem. The fluid transfer system 1200 can thereby reduce or eliminatethe risk of injury, waste, or damage caused by liquid or vapor leakagewhen connecting and disconnecting the components of the fluid transfersystem 1200.

Each transfer station 1218 a-b can include a fluid source container 1220a-b, which can be, for example, a medical vial or other suitablecontainer such as a bag, a bottle, or a vat, etc. Although manyembodiments disclosed herein discuss using a vial as the sourcecontainer, it will be understood the other containers can be used evenwhen not specifically mentioned. In some embodiments, each of the sourcecontainers 1220 a-b can contain a unique fluid, providing a variety offluids that the user can select for transfer. In other embodiments, twoor more of the source containers 1220 a-b can contain the same fluid. Insome embodiments, the source containers 1220 a-b include bar codes thatidentify the types of fluid contained therein. The bar codes can bescanned by a bar code scanner 1205 that is in communication with thecontroller 1204 and/or the memory 1206 (e.g., via the communicationinterface 1210) so that the identities of the fluids contained by sourcecontainers 1220 a-b can be stored within the memory module 1206. In someembodiments, the fluid transfer stations 1218 a-b are configured totransfer precise amounts of fluid from source containers 1220 a-b to atarget container 1224, which can be, for example an IV bag. It will beunderstood that in various embodiments described herein, a differenttype of target container or destination container can be used instead ofan IV bag (e.g., a syringe, a bottle, a vial, an elastomeric pump, etc.)even when not specifically mentioned.

In some embodiments, the system 1200 can include source adapters 1236a-b configured to receive the source containers 1220 a-b and removablyconnect to the connectors 1226 a-b. Thus, when a source container 1220a-c runs out of fluid, the empty source container 1220 a-b and itscorresponding adapter 1236 a-b can be removed and replaced withoutrequiring disengagement of the associated connector 1226 a-b from thehousing 1202. In some embodiments, source adapters 1236 a-b can beomitted, and the source containers 1220 a-b can be directly received bythe connectors 1226 a-b.

In some embodiments using two fluid or more transfer stations 1218 a-b,the fluid transfer system 1200 can be used to transfer and combineindividual fluids from the source containers 1220 a-b to the targetcontainer 1224. The system 1200 can be used for compounding mixtures offluids. For example, the system 1200 can be used to combine multiplemedications together or to combine feeding fluids (e.g., water,dextrose, lipids, vitamins, minerals). The system 1200 can also be usedto dilute a medication or other fluid to a desired concentration level.In some embodiments, a first fluid transfer station 1218 a can include aconcentrated medication or other fluid, and a second fluid transferstation 1218 b can include saline or other diluent. The system 1200 canbe configured to receive input (e.g., from a user or from a hospitalinformation system) indicating a desired amount and concentration ofmedication, and the system 1200 can be configured to transfer theprecise amounts of the concentrated medication and the diluent requiredto fill the source container 1224 a with the desired amount andconcentration of the medication. The system can calculate the amountthat needs to be transferred from each fluid transfer station 1218. Theoperation can then be done serially by transferring a first fluid fromthe first transfer station 1218 a and then separately transferring asecond fluid from the second transfer station 1218 b. In someembodiments, a technician can manually connect the first fluid transferstation 1218 a, via connector 1230 a, to the target container 1224.After the first fluid is transferred the connector 1230 a isdisconnected and second fluid transfer station is connected, viaconnector 1230 b, to the target container 1224 to transfer the secondfluid. In some embodiments, the system 1200 can include an actuator thatis capable of automatically switching the connection of the targetcontainer 1224 between the fluid transfer stations 1218 a-b. In someembodiments, the actuator can switch between different fluid sources atthe same fluid transfer station. For example, the first fluid source canbe a concentrated medication or other fluid, and a second fluid sourcecan be saline or other diluent.

In some embodiments, the system 1200 can include compatibility modules1232 a-b for permitting connections with approved connectors 1226 a-b,and for preventing connectors other than approved connectors 1226 a-bfrom being placed in communication with the system 1200. Thecompatibility modules can be, for example, a specifically shapedmounting feature (e.g., on the housing of the fluid transfer station)that is configured to interface with a corresponding portion of theconnector 1226 a-b, 1230 a-b. In some embodiments, the compatibilitymodules 1232 a-b can be one or more sensors configured to detect thepresence of an approved connector 1226 a-b or to align with a specificportion of the connector 1226 a-b during operation.

In some embodiments the system 1200 can include sensors 1234 a-b fordetecting the presence of the target container 1224. Sensors 1234 a-bcan be in communication with the controller 1204 so as to prevent thesystem 1200 from attempting to transfer fluid when no target container1224 is connected. A variety of sensor types can be used for sensors 134a-b. For example, sensors 1234 a-b can be weight sensors, sensor pads,infrared sensors, or other forms of electronic sensors. In someembodiments, the sensor 1234 a-b can align with a substantiallytransparent portion of the connector 1226 a-b to detect whether a valveon the connector 126 a-b leading to target container 1224 a-b is open.If open, the sensor 1234 a-b can send a signal to the controller 1204 sothat fluid transfer is permitted. The sensors 1234 a-b can be configuredto align properly with only approved connectors 1226 a-b so that thesensors 1234 a-b do not allow fluid transfer if an unapproved connectoris used. Thus, the sensors 1234 a-b can be used as the compatibilitymodules 1232 a-b in some embodiments.

The fluid transfer system 1200 can have many different configurations.For example, in some embodiments there is only a single fluid transferstation. In some embodiments, certain features shown in FIG. 60 can beomitted for some or all of the transfer stations. For example, in someembodiments, a fluid transfer station can have the sensors omittedbecause, for example, a particular peristaltic pump does not generatesufficient pressure to cause fluid to leak out the connector when atarget container is not connected and the pump is running.

FIG. 61 is an example embodiment of a fluid transfer system 1300, whichcan have features similar to, or the same as, the system 1200 describedabove or any other fluid transfer system described herein. FIG. 62 is afront view of the fluid transfer system 1300 and FIG. 63 is a back viewof the fluid transfer system 1300. In FIGS. 62 and 63, certain features(i.e., the fluidics assembly) are omitted from view. The system 1300 caninclude a fluid transfer station 1318 and a weight sensor 1322.

The fluid transfer station 1318 includes a housing 1302, a peristalticpump 1350, a motor (not shown), a user interface 1208, and a poleassembly 1342. The user interface 1208 can be incorporated into thehousing. The user interface 1208 can include a touchscreen, a keypad, adisplay, or other suitable interface devices for providing informationto a user and/or for providing input from the user to a controller (notshown).

As can be seen in FIG. 63, the fluid transfer station 1318 and theweight sensor 1322 can have communication interfaces 1310 a-b. Thecommunications interfaces 1310 a-b can include one or more connectionpoints to receive cables from one or more remote sources such as aremote terminal (e.g., a computer) or an automated management system(e.g., a hospital information system (HIS)). The fluid transfer station1318 and the weight sensor 1322 have a communication link establishedbetween them, such as by cable 1312. In some embodiments the weightsensor 1322 and the fluid transfer station can establish a communicationusing wireless signal.

In some embodiments, the communication interfaces 1310 a-b can beconfigured to provide a communication link between the system 1300(i.e., the fluid transfer station and the weight sensor) and a remotelocation. The communication link can be provided by a wireless signal(e.g., using an antenna) or by one or more cables or a combinationthereof. The communication link can make use of a network such as a WAN,a LAN, or the internet. In some embodiments, the communicationinterfaces 1310 a-b can be configured to receive input (e.g., fluidtransfer commands) from the remote location and/or can provideinformation (e.g., results or alerts) from the system to the remotelocation.

The fluid transfer station 1318 can be configured to transfer fluid froma vial 1320 to an IV bag 1324 using a peristaltic pump 1350. The fluidis transferred from the vial 1320 through a connector 1326, and into ahose assembly 1328. The peristaltic pump 1350 moves the fluid from thehose assembly 1330 through the connector 1328 and into the IV bag 1324.The operation of the peristaltic pump 1350 is controlled by thecontroller based on commands or information received from a user. Anexample of the fluidics assembly is described in additional detail belowwith additional reference to FIGS. 64 and 65. Operation of an embodimentof a peristaltic pump is described in additional detail below withreference to FIGS. 66 through 68.

The fluid transfer station 1328 can include a pole assembly 1342, whichcan be configured to hold fluid containers such as vials and fluid bags.A pole 1344 can extend upward from the housing 1302, and in someembodiments, the pole 1344 can be height adjustable and thumb screw 1346can be tightened to hold the pole 1344 in place. The thumb screw 1346can be loosened to enable adjustment of the height of the pole 1344, andin some embodiments, the pole 1344 can be lowered into a recess formedin the housing 1302 that is configured to receive the pole 1344. thepole 1344 can be entirely, substantially entirely, or mostly withdrawninto the housing 1302 when the pole 1344 is not in use (e.g., duringstorage or transportation or when not needed to support fluidcontainers). One or more support modules 1348 can be attached to thepole 1344 and can be configured to support fluid containers. The supportmodules 1348 can include thumb screws so that the positions of thesupport modules 1348 on the pole 1344 can be adjustable, and/or so thatthe support modules 1348 can be removable from the pole 1344. In theillustrated embodiment, the support module 1348 can have one or morecurved arms for supporting a fluid container such as vial 1320.

In some embodiments, the weight sensor can include a housing 1316, auser interface, and a weighing surface 1321. The user interface 1318 canbe incorporated in the housing 1316. The user interface 1318 can providea visual indication of weight, and other information. In someembodiments the weight sensor 1322 can receive commands or instructionsthrough the user interface 1318 from a user. In some embodiments theweight sensor 1322 does not include a user interface 1318. The weighingsurface 1321 is configured to provide a surface for the IV bag. Theweighing surface 1321 can be sized so that the IV bag 1324 or othertarget container can be properly balanced and positioned on the weightsensor.

The weight sensor 1322 can provide information to (e.g., measurements,current state of operation, etc.) and receive commands (e.g., zeroingthe weight sensor) from the fluid transfer station 1318 through thecommunication interface 1310 b. The weight sensor 1322 is used todetermine the amount of fluid transferred from the vial 1320 to the IVbag 1324.

FIG. 64 is a perspective view of a fluidics assembly 1339 that can beused with the fluid transfer station 1318. FIG. 65 is a perspectiveexploded view of the fluidics assembly 1339 shown in FIG. 64. The fluidassembly 1339 can be used to transfer precise amounts of fluid from avial 1320 to an IV bag 1324. The fluidics assembly 1339 includes a vial1320, a vial adapter 1352 configured to provide fluid communication withthe fluid (e.g., chemotherapy drug or other medication) contained withinthe vial 1320 to a connector 1326, a tubing assembly 1330, a connector1328, and the IV bag assembly 1324. In some embodiments, the fluidicsassembly 1339 can have features similar to, or the same as, those of theother fluidics systems disclosed herein. For example, the connector 1326can be the same or substantially similar to the connector 1226 a, alsodiscussed herein. In some embodiments, the fluidics assembly 1339 can beconfigured to allow the vial 1320 and vial adapter 1352 to be replaced(e.g., when the vial runs out of fluid) without replacing the connector1326 or the tubing assembly 1330. In some embodiments, the vial adapter1352 can be configured to allow air to enter the vial 1320 via the vialadapter 1352, thereby substantially equalizing pressure in the vial 1320as fluid is drawn out.

A tubing or hose assembly 1330 can extend between the connector 1326 andthe connector 1328. The tubing assembly includes first tube portions1334, a second tube portion 1332, and tubing connectors 1336. The secondtube portion 1332 is configured to be inserted within the peristalticpump 1350. In some embodiments the second portion 1332 can be configuredto be more flexible than the first portion 1334. In some embodiments thesecond tube portion 1332 can be configured to have a lower durometervalue than the first portions 1334. In some embodiments, the secondportion 1332 can be more compressible than the first portion 1334 at agiven force. In some embodiments, the tube 1332 can be formed fromsilicone rubber, or other appropriately formed elastomeric materials.The tube portions 1334 are positioned between the connectors 1326, 1328and the tubing connectors 1336. In some embodiments the first tubeportions 1334 can be smaller diameter tubing than is used for the secondtube portion 1332. The tubing connectors 1336 are configured to create afluid tight seal between the second tube portion 1332 and the first tubeportions 1334. In some embodiments, there are no first tube portions1334 or tubing connectors 1335 and the second tube portion 1332 iscoupled to the connector 1326 and the connector 1328.

A connector 1326 (e.g., a Spiros® closeable male connector or a firstChemolock™ connector manufactured by ICU Medical, Inc., of San Clemente,Calif.) can be located at the end of the tubing assembly 1330 and can beused to connect to a corresponding connector 1334 (e.g., a Clave®connector or a second Chemolock™ connector manufactured by ICU Medical,Inc., of San Clemente, Calif.) that is attached to the fluid sourcecontainer 1320. Additional details relating to Clave® connectors andsome variations are disclosed in the '866 patent. In various embodimentsdisclosed herein, other types of connectors can also be used, such as aMicroCLAVE® connector (manufactured by ICU Medical, Inc., of SanClemente, Calif.), or any other connector disclosed or described herein,including those in the '302 application, including, for example, clearconnectors. When the connectors 1326 and 1334 are engaged, a fluidconnection exists between the fluid source container 1320 and theconnector 1326. A tube 1330 can extend from an outlet of the connector1326 to a connector 1328 (e.g., a Spiros® closable male connector) canbe positioned at the opposite end of the tubing assembly 1330. Acorresponding connector 1338 (e.g., a Clave® connector) can engage theconnector 1328. The IV bag 1324 may have a supplemental line of tubing1325 that can be configured to engage the connector 1338 to provide afluid connection between the connector 1328 and the IV bag 1324.

FIGS. 66 through 68 illustrate an embodiment of a peristaltic pump 1350used by the fluid transfer station 1318. The peristaltic pump has acover 1352, a mounting interface 1354, a plurality of lobes 1356, arotor 1358, and a motor (not shown). The peristaltic pump is a positivedisplacement pump used for pumping fluid from the vial 1320 to the IVbag 1324. The fluid is transferred via a compressible tube 1332 fittedinside the mounting interface 1354. The rotor 1358 has a plurality oflobes 1356 attached to the external circumference of the rotorcompresses the flexible tube. In some embodiments the lobes can berollers, shoes, wipers, or other members that facilitate the operationof the pump. As the rotor turns, the part of tube under compression iscompressed, or occludes, thus forcing the fluid to be pumped to movethrough the tube. As the tube 1332 opens to its natural state after thepassing of the lobes 1356 fluid flow is induced.

In some embodiments of the pump 1350, as illustrated the cover 1352 isopened (see FIG. 66), the tube 1332 is positioned within the mountinginterface 1354 (see FIG. 67), and the cover is closed. FIG. 68illustrates the tubing 1332 mounted within the pump 1350 duringoperation. As shown the peristaltic pump lobes pinch the tube andcompress the tubing, thereby moving fluid through the tube 1332.

The flow rate of the fluid through the pump 1350 can be controlled bythe speed of the pump motor. The motor can be a variable speed motor andthe fluid flow rate can be precisely controlled by varying the speed ofthe motor.

The peristaltic pump can operate at low pressures, and can avoidbuilding up high pressures if the tubing is not connected to the IV bag.The pressures can be sufficiently low that the connector 1328 does notleak when it is closed and the pump is operating and connected to afluid source, such as the vial 1320. In some embodiments, the systemdoes not include sensors for detecting the presence of a targetcontainer.

Additionally, the system does not include sensors, in some embodiments,for detecting air bubbles because the system uses the weight of thetarget container to determine when the correct amount of fluid istransferred. The pump can continue to operate until the desired amountof fluid has been transferred to the target container.

FIG. 69 is an example of a flowchart for a method of using a fluidtransfer system to transfer fluid from a source container to a targetcontainer 1360. The fluid transfer system can use the same or similarcomponents as the fluid transfer systems 1200 and 1300 described herein.At block 1362, source container (e.g., a medical vial or other suitablecontainer such as a bag, a bottle, or a vat, etc.) is coupled to a fluidtransfer station. The source container contains fluid (e.g.,chemotherapy drug or other medical fluid). The source container can havea compatible adapter device. The source container is in fluidcommunication with a tubing assembly. The tubing assembly is in fluidcommunication with a target container (e.g., an IV bag, an elastomericpump, a syringe, or other suitable container). The tubing assembly canbe a closed system that retains substantially entirely, or entirely, allof the fluid within the assembly, permitting the fluid transfer to occurin a substantially entirely, or entirely, closed system. A closed systemcan reduce or eliminate the risk of injury, waste, or damage caused byliquid or vapor leakage when connecting and disconnecting the componentsof the fluidics system. The source container can be mounted on a fluidtransfer station. The fluid transfer station can include a housing thatincorporates a peristaltic pump, controller, user interface, andcommunication interface. The tubing assembly has a portion of tubingmounted within a peristaltic pump.

At block 1364 a target container (such as an IV bag, an elastomericpump, a syringe, or other appropriate target container) is coupled tothe opposite end of the tubing assembly. The target container ispositioned on a weight sensor. The weight sensor is configured to weighthe target container to determine the amount of fluid that istransferred into the target container. The weight sensor can beincorporated in a separate housing from the fluid transfer station. Theweight sensor can have a communication interface and can be incommunication with the controller. The weight sensor can provideinformation to the controller and receive instructions from thecontroller.

At block 1366, the fluid transfer station receives a command to transfera specific amount of fluid from the source container to the targetcontainer. A user can provide commands through the user interface on thefluid transfer station. In some embodiments the commands can be receivedby a remote source. The user can identify a specific amount of fluidthat is to be transferred (e.g., 10 ml, 30, ml, 100 ml, etc.) to thetarget container. After determining the amount of fluid to betransferred, the user can instruct the fluid transfer system to proceedwith the transfer. In some embodiments the fluid transfer system canverify that the user has entered in the correct amount of fluid to betransferred.

At block 1368, the fluid transfer station processes the commands andprepares the system to transfer the fluid to the target container. Thecontroller zeros the weight sensor to compensate for other masses in thesystem, such as the weight of the target container assembly. This allowsthe scale to determine the amount of fluid that will be transferred tothe target container. After the scale has been zeroed the controller caninitiate the transfer of fluid to the target container.

At block 1370, the controller instructs the motor of the peristalticpump to operate pumping until the weight of the scale meets thespecified weight of transferred fluid in the target container. The motorcan vary the speed of the peristaltic pump based on the amount of fluidto transfer to the target container. As the amount of fluid approachesthe specified amount, the speed of the motor can slow down, therebyreducing the flow rate of fluid into the target container, in order toincrease accuracy. The controller can use an algorithm to determine theappropriate speeds at which to operate the pump. In some embodiments thecontroller can determine the flow rate associated with different speedsof the motor. The controller will continue to operate the motor untilthe specified amount has been transferred to the target container.

At block 1372 additional source containers can be coupled to the fluidtransfer station. The source containers can continue to be replaceduntil the specified amount of fluid has been transferred to the targetcontainer. In some embodiments the motor can stop when the controllerdetects that the source is disconnected. In other embodiments the pumpcontinues to operate until the specified weight is achieved regardlessof whether the source container is disconnected. In some embodiments thecontroller can determine that fluid is not being transferred from thesource container to the target container. In some embodiments thecontroller can receive input from a sensor to determine whether thesource container is empty. In some embodiments the controller candetermine that fluid is not being transferred from the source containerbecause the motor is operating but fluid is not being transferred. Insuch instances, the controller can provide an audible alarm to the user,stop the operation of the motor, and/or perform other appropriateactions. A reservoir container (as described in FIGS. 53 and 54) can beused to transfer the contents of multiple source containers to thereservoir container prior to transferring the fluid to the targetcontainer.

In some embodiments, the fluid transfer system can be configured toclear fluid out of the fluidics system, either automatically or uponinstructions received from an operator (e.g., using a “clear” button).FIG. 70 is a flowchart showing an example method 1400 of a fluidclearing method. At block 1402, the system can transfer fluid. Forexample, the system can actuate a peristaltic pump to draw fluid out ofa source container (e.g., vial) and to transfer the fluid into a targetcontainer (e.g., IV bag), as described herein. Once the specified amountof fluid has been transferred, the target container can be removed atblock 1404. In some embodiments, another target container can beattached to the system and another fluid transfer procedure can beperformed using the same type of fluid drawn from the same sourcecontainer. In some embodiments, the source container can be removed atblock 1406, for example, if no additional fluid transfers are to beperformed or if the next fluid transfer is for a different type offluid. In some embodiments, a volume of fluid remains in the connectorafter a fluid transfer. The fluid transfer system can flush theremaining fluid out of the connector so that the flushed fluid (whichcan be expensive) can be recovered for later use.

At block 1408, a new target container can be attached to receive theflushed fluid. For example, the vial (or other container) that was usedas the source container for the fluid can be attached to the system asthe target container so that the flushed fluid can be directed back intothe container were it started. In some embodiments, the vial orassociated vial adapter can be configured to regulate pressure in thevial as the flushed fluid is inserted therein, for example, by deflatinga volume variable bag associated therewith, as described in the '157Publication. In some embodiments, the vial and/or vial adapter does nothave a variable volume component and the volume inserted into the vialcan be small enough that the pressure in the vial is not raised beyondan acceptable threshold.

At block 1410, a new source attachment can be attached to the system.The source attachment can allow air to be drawn into the connector. Forexample, the new source attachment can be an empty vial and adaptersimilar to the vial 3907 and adapter 3908 of FIGS. 7 and 8. Air canenter through the filter 3948 and pass through the empty vial 3907, passthrough the female connector 3944, and enter the connector to flush thefluid contained therein. In some embodiments, the source attachment doesnot include a vial or other container. For example, FIG. 46 shows anexample embodiment of an air source attachment 770 that includes aconnector 772 that is configured to engage the source connector portionof the connector being flushed. An air intake element 774 can beattached to the connector 772. The air intake element 774 can include aone-way air valve or filter 776 configured to allow air to enter the airintake element 774 and to prevent air from exiting through the filter776. A pathway can lead from the filter 776 to the connector 772 toallow air to enter through the filter 776 and travel through theconnector 772. In some embodiments, the air intake element can beintegrally formed with the connector, for example, by placing the filter776 at the male end of the connector 772 shown.

In some embodiments, the peristaltic pump does not produce enoughpressure to flush the connectors and tubing assembly with the air intakevalve 774 providing air at ambient pressure. The connector can beconnected to a pressurized air source. The pressurized air source canprovide sufficient pressure to flush the fluidics system.

In some embodiments, a fluid source container can be attached at block1410, for example, to flush the fluid out of the connector using salineor water. However, in some embodiments, the fluid being flushed canbecome diluted or contaminated by the flushing fluid. It can beadvantageous to use air in some embodiments. In some embodiments aflushing fluid can be used, such as a cleaning liquid, to flush theconnector in order to clean the connector. In some embodiments, theconnector can be cleaned for later use. In some embodiments, theconnector can be disposable, and can be cleaned with a flushing fluidprior to being discarded, for example, if the transferred fluid ishazardous.

At block 1412, the system can flush fluid from the connector through atubing assembly and into the target container (e.g., into the vial thathad been used as the source container). For example, the peristalticpump can draw air (or other flushing fluid) through the inlet of theconnector and the peristaltic pump can then push the air out through thehosing assembly and the connector outlet towards the target container sothat the air drives some or all the fluid into the target container(e.g., the vial that had been the source container). In some embodimentsthe peristaltic pump is connected to a pressurized air source to flushthe connectors and tubing assembly. In some embodiments, the system canflush the connector at block 1412 in response to input received from auser or from an outside system, such as by pressing a user indicator,such as a “clear cassette” or “flush” button.

In some embodiments a workflow and/or data management system is used tomonitor and track the preparation of medications using the fluidtransfer systems. The workflow and/or data management system can providea process for preparing and reporting medications. The workflow and/ordata management system can provide a system that provides and storesprocesses, instructions, patient data, and monitoring procedures to helpensure that the correct medications, dosages, and diluents are used.This can increase patient safety, efficiency, and result in reduced drugwaste and cost.

The workflow and/or data management system can be a distributednetwork-based system that provides remote access to the system. Thesystem can provide a centralized processing system that maintains all ofthe information associated with the preparation of medications. Labs andworkstations can communicate with the centralized system.

The workflow and/or data management system can include scanners,cameras, printers, and/or electronic storage systems for tracking andcataloguing the workflow process. The system can have a scanner forreceiving information about fluid containers, medicaments,prescriptions, instructions, and or patients, such as by scanning barcodes, QR codes, or receiving data such as RFID data. Each medicine canhave a code that is stored within the system that allows the system tokeep track of them and verify that the proper medicine is being used inthe process. The system can also utilize cameras to document one or moreof the steps of the process. In some embodiments images can be capturedof one or more medicines and components used in the process. In someembodiments, video can be used to record the portions of thepreparation. In some embodiments a printer utilizing a real-time clockcan be used to catalogue the timing of the workflow. The real-time clockcan help ensure that the proper time is printed on each label.

FIG. 71 illustrates a method of using a workflow and/or data managementsystem 1450. At block 1452 a dosage is selected for processing. Thedosage can be provided to the user by a computer system that queues andstores the dosages that need to be prepared. In some embodiments theworkflow and/or data management system can provide the dosages forprocessing based on one or more criteria. One criterion for processingdosages can be the need, urgency, or timing of the dosage for a patient.The workflow management system can also select dosages for processingbased on efficiency. For example, the workflow system can group theprocessing of the same type of dosages. In some embodiments the user canselect the dosage for processing from a list.

At block 1454, the selected dosage is prepared for processing. Theworkflow and/or data management system can provide instructions onpreparation of the selected dosage. A dose label can be printed thatwill be placed on the completed dosage. The label can includeinformation about the dosage, such as patient name, ingredients used inthe application, and the time of processing. The label can also includea unique code, such as a bar code or QR code. The label can be placedonto the proper container and scanned by the workflow and/or datamanagement system. In some embodiments the label for the completeddosage is prepared after the preparation is complete.

The workflow and/or data management system identifies each ingredient orcomponent of the dosage. The workflow and/or data management system canalso require that each component is scanned and photographed. This canhelp ensure that the correct ingredients with the correct concentrationsare used for each medicine. If the incorrect component is scanned, theworkflow and/or data management system can instruct the user to scan anduse the correct component before proceeding.

At block 1456, the products used in the dosage can be compounded asnecessary. The workflow and/or data management system can provide stepby step instructions on compounding the dosages. The fluid transfersystems described herein can be used to compound the components. Forexample, the fluid from one or more source containers can be combined,or compounded, into a single target container.

In some embodiments the workflow and/or data management system canautomate, control, and/or store information about the fluid transfersystem. The user can couple the correct source and target containers tothe fluid transfer system and instruct the workflow and/or datamanagement system to proceed. In some embodiments the fluid transfersystems can have scanners that can be used to verify that the propercomponents are coupled to the system. The workflow and/or datamanagement system can provide instructions to the fluid transfer systemsto transfer the specified amount of fluid from the source container tothe target containers. This process can help reduce error associatedwith the user entering the incorrect information into the fluid transfersystem.

At block 1458, the dosage is verified. After the compounding proceduresare complete, the dosage is removed from the fluid transfer system andverified by the workflow and/or data management system. The workflowand/or data management system can take a picture of the container andpictures of each of the components used to formulate the dosage andstore one or more pictures of the process in a database. These picturescan be available for later retrieval by a user, and can be used to helpverify that the proper amounts were transferred from each component. Theworkflow system can also scan labels on each component and the on thecompleted dosage. In some embodiments a label is printed after theprocess is complete and placed on the prepared medicine. In someembodiments, after all the information has been catalogued andprocessed, a user, such as a pharmacist, can access the information froma remote location. The user can review and either approve or reject theprepared medicine. Information regarding the timing, drug type, dosage,technician, patient identity, and/or patient diagnosis, or other storedinformation can be later retrieved from a database.

Embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the foregoingembodiments have been described at a level of detail to allow one ofordinary skill in the art to make and use the devices, systems, etc.described herein. A wide variety of variation is possible. Components,elements, and/or steps may be altered, added, removed, or rearranged.Additionally, processing steps may be added, removed, or reordered.While certain embodiments have been explicitly described, otherembodiments will also be apparent to those of ordinary skill in the artbased on this disclosure.

Some aspects of the systems and methods described herein canadvantageously be implemented using, for example, computer software,hardware, firmware, or any combination of software, hardware, andfirmware. Software can comprise computer executable code for performingthe functions described herein. In some embodiments, computer-executablecode is executed by one or more general purpose computers. However, askilled artisan will appreciate, in light of this disclosure, that anymodule that can be implemented using software to be executed on ageneral purpose computer can also be implemented using a differentcombination of hardware, software, or firmware. For example, such amodule can be implemented completely in hardware using a combination ofintegrated circuits. Alternatively or additionally, such a module can beimplemented completely or partially using specialized computers designedto perform the particular functions described herein rather than bygeneral purpose computers.

While certain embodiments have been explicitly described, otherembodiments will become apparent to those of ordinary skill in the artbased on this disclosure. Therefore, the scope of the invention isintended to be defined by reference to the claims as ultimatelypublished in one or more publications or issued in one or more patentsand not simply with regard to the explicitly described embodiments.

What is claimed is:
 1. A medical fluid transfer system comprising: athree-way connector having a first closable connector configured tocouple to a source container, a second closable connector configured tocouple to a target container, and a syringe interface; a syringe pump influid communication with the syringe interface and configured totransfer fluid through the three-way connector; a destination sensorconfigured to detect whether or not the target container is connected tothe second closable connector and to output information indicatingwhether or not the target container is connected; a fluid switch havinga first configuration and a second configuration, wherein the firstconfiguration of the fluid switch opens a fluid pathway between thesource container and the syringe pump, and wherein the secondconfiguration of the fluid switch closes the fluid pathway between thesource container and the syringe pump; an actuator configured to togglethe fluid switch between the first and second configurations; one ormore cameras configured to capture images of one or more components todocument one or more steps of a fluid transfer process performed by thefluid transfer system; and a control system configured to: receiveinstructions, wherein the instructions comprise a fluid transferinstruction to transfer a specified volume of fluid from the sourcecontainer to the target container; operate the syringe pump and actuatethe fluid switch to open and close the fluid pathway between the sourcecontainer and the syringe pump based on the fluid transfer instructions;receive the information indicating whether or not the target containeris connected from the destination sensor; and operate the syringe pumpbased on the information received from the destination sensor, whereinthe control system prevents the system from attempting to transfer fluidwhen the target container is not connected.
 2. The medical fluidtransfer system of claim 1, wherein the destination sensor comprises aweight sensor.
 3. The medical fluid transfer system of claim 1, whereinthe first closable connector is configured to removably couple to thesource container and the second closable connector is configured toremovably couple to the target container.
 4. The medical fluid transfersystem of claim 3, wherein the first closable connector is a closablemale connector and the second closable connector is a closable maleconnector.
 5. The medical fluid transfer system of claim 1, wherein thedestination sensor is configured to detect whether the second closableconnector is open.
 6. The medical fluid transfer system of claim 1,wherein the control system is configured to receive instructions from aremote source.
 7. The medical fluid transfer system of claim 1, furthercomprising a scanner configured to scan information on the sourcecontainer and the target container.
 8. The medical fluid transfer systemof claim 7, wherein the control system is further configured to receiveinformation from the scanner and store the information received from thescanner.
 9. The Medical fluid transfer system of claim 1, wherein thefluid switch is a stopcock.
 10. The medical fluid transfer system ofclaim 1, wherein the syringe pump stops when the control system receivesinformation indicating that the source container is disconnected. 11.The medical fluid transfer system of claim 1, further comprising: one ormore sensors configured to detect whether or not the three-way connectoris present, wherein the control system is configured to not allow fluidtransfer when the three-way connector is not detected; and a mountingmodule configured to align the three-way connector with the one or moresensors.
 12. The medical fluid transfer system of claim 1, wherein thesyringe pump is configured to removably engage the syringe interface.